Methods and systems of fitting, evaluating, and improving therapeutic compression garments

ABSTRACT

The present invention relates to methods of fitting for pre-fabricated compression garments via digital imaging of a wearer body part and measurement of body part circumferences and, optionally, lengths therefrom. The present invention also relates to methods of generating a shape description derived from digital imaging of a patient body part or body area of interest and use of such shape description. Such shape description includes geometric information from which measurement information can optionally be derived. Included herein are methods for diagnosing and monitoring edema and other conditions in patients using shape descriptions acquired from a patient in need of such diagnosis and monitoring. The invention also includes use of the generated shape descriptions to make compression garments specifically configured for a patient&#39;s body part or body area. Compression garments generated from the generated shape descriptions are also included herein.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of and claims priority to U.S. patentapplication Ser. No. 16/357,090, filed Mar. 18, 2019, which is aContinuation of and claims priority to U.S. patent application Ser. No.15/896,765, filed Feb. 14, 2018, which is a Continuation in Part fromand claims priority to U.S. patent application Ser. No. 15/674,152,filed Aug. 10, 2017, which claims priority to and the benefit of U.S.Provisional Application No. 62/372,891, filed on Aug. 10, 2016. Thedisclosure of all of these applications are incorporated herein in theirentirety by this reference.

FIELD OF THE INVENTION

The present invention relates to methods of fitting for pre-fabricatedcompression garments via digital imaging of a wearer body part andmeasurement of body part circumferences and, optionally, lengthstherefrom. The present invention also relates to methods of generating ashape description derived from digital imaging of a patient body part orbody area of interest and use of such shape description. Such shapedescription includes geometric information from which measurementinformation can optionally be derived. Included herein are methods fordiagnosing and monitoring edema and other conditions in patients usingshape descriptions acquired from a patient in need of such diagnosis andmonitoring. The invention also includes use of the generated shapedescriptions to make compression garments specifically configured for apatient's body part or body area. Compression garments generated fromthe generated shape descriptions are also included herein.

BACKGROUND OF THE INVENTION

“Edema” is the accumulation of excess fluid in a fluid compartment. Thisaccumulation can occur in the cells (i.e., cellular edema), in theintercellular spaces within tissue (i.e., interstitial edema), or inother spaces in the body. Edema can be caused by a variety of factors,including indications associated with osmotic pressure, such ashypotonic fluid overload, which allows the movement of water into theintracellular space, or hypoproteinemia, which decreases theconcentration of plasma proteins and permits the passage of fluid out ofthe blood vessels in to the tissue spaces. Other factors can includepoor lymphatic drainage (known as “lymphedema”), conditions associatedwith an increased capillary pressure (e.g., excessive retention of saltand/or water), heart failure, and conditions associated with increasedcapillary pressure, such as inflammation.

When a person is symptomatic of edema, early diagnosis and treatment isimperative. As swelling increases, more pressure is exerted onsurrounding cells, tissues and blood vessels. As these areas aresqueezed from the increase of fluid and from the natural body responseto increased inflammation (as a component of “first response” to aninjury), more tissues die, more fluids are released, and the amount ofedema presented increases. As edema increases, there is more potentialfor this “cascade effect” to continue, to result in even more damage.Thus, early diagnosis and regular patient monitoring can be critical toidentify swelling occurring prior to the generation of the “edemacascade.”

Compression garments can be used to prevent and or treat edema and anumber of conditions that cause swelling in patient body parts or bodyareas. In this regard, edema, which as indicated, presents as excessiveinterstitial fluid accumulation, may arise from a variety of illnessesand conditions, including venous valvular insufficiency, post-phlebiticsyndrome, posttraumatic swelling, postoperative swelling, congestiveheart failure-related swelling, hypoalbuminemia-related swelling, druginduced swelling, and lymphedema.

In the treatment of edema-like conditions, compression garments canaddress patient body part or body area swelling by increasing transportand reducing stagnation of interstitial fluids. Such interstitial fluidsoperate to increase nutrient delivery to tissue, remove waste fromtissues, reduce pain from swelling, and decrease the risk of infection.

For therapeutic use, that is, compression that is prescribed by aclinician for treatment of one or more medical indications, properfitting of compression garments is important if only because ill-fittinggarments will not provide the intended/prescribed amount of compressiontherapy to the person being treated. Existing methods of fittingcompression garments for a specific patient are problematic, however. Aswould be understood, human body parts or body areas that may be fittedwith compression garments are not regularly shaped, and some may bequite complex in surface shape or morphology, such as in patients withadvanced lymphedema or those who are morbidly obese, for example.

A further concern in the design of a therapeutic compression garment ispatient comfort. A compression garment may provide proper compressioncharacteristics, but if the wearer experiences discomfort due topinching, chaffing, buckling, or other reasons, she is unlikely to becompliant in wearing the compression garment and, thus, may not achievetherapeutic benefits. For example, the noncompliance rate for graduatedcompression stockings has been reported to be 30%-65%. Commonly citedreasons include, among other things, pain, discomfort, difficultydonning the stockings, perceived ineffectiveness, excessive heat, andskin irritation. Of course, if a patient fails to wear a compressiongarment that is prescribed for a potentially chronic or already chroniccondition, that condition can become worse and, perhaps, irreversibledamage could result. Thus, improved patient compression garmentcompliance is a need today.

Given the vast variation in human body shapes, custom garments can beindicated to provide optimum therapeutic benefits. Traditionally,compression garment fitting has been conducted primarily by use of atape measure. While tape measurement techniques are widely available toa broad scope of medical providers, the technique generally suffers frompoor accuracy. In short, tape measurement is not a very effectivegarment measurement tool because the technique has been shown to exhibitas much as an about 8 to about 12% inaccuracy due to inter andintra-operator variability. Such variability gives rise to a need formethods of measurement that demonstrate improvements in both accuracyand precision.

In therapeutic settings, patients often receive a recommendation for acustom fit garment, even though a custom fit garment is often far moreexpensive than an pre-fabricated compression garment. The time needed togenerate such custom fit garments is long: the patient must be measuredby a trained technician, and such measurements must be forwarded to agarment manufacturer, before the garments can be placed in a queue formanufacturing.

As noted, the current methodology used to fit compression garments isoften inaccurate. Thus, using current fitting methodology, evenexpensive custom fit garments may not fit properly even when they arenew. This means that, once the garments are sent back from themanufacturer, the fit quality must be checked by the technician and/ormedical provider to make sure that the fit is therapeutically correct,thus necessitating further delays and increased cost in ensuring properpatient treatment. Often these custom-made compression garments must beremade; the fit error rate has been estimated to be from about 15 toabout 40%. For chronic conditions, such as lymphedema or diabetic limbindications, such delay can cause irreversible harm to the patient. As ageneral rule, compression garments are usually only guaranteed to betherapeutically effective for a life of six months, this cycle must berepeated regularly, which can reduce patient compliance, as well asgreatly adding to the cost of treatment given the high amount ofin-person time a patient requires to ensure proper fit of thecompression garment.

In addition to therapeutic effectiveness, compression garments are anincreasingly popular clothing item worn by athletes and activeindividuals with the goal of enhancing recovery from exercise. As ageneral rule in medicine, particularly in orthopedics, when people havepain or instability, compression provides some improvement in symptoms.While the actual mechanism of action for compression clothing inathletic-type uses remains largely unknown today, it is generallyhypothesized that when compression garments are used during recoveryafter exercise, muscle swelling is reduced. Improvements in recoveryafter exercise are seen by both men and women, who can be well-trainedathletes or “weekend warriors.” Generally, it seems likely thatcompression garments display greater overall benefits following higheramounts of, or greater intensities of, exercise. Some research indicatesthat compression garments may provide a “placebo effect” for users.Nonetheless, such a “placebo effect” may be beneficial if only becauseit increases the likelihood that a person will continue to exercisebecause they do not feel as injured.

Notwithstanding the lack of clear knowledge about how compressiongarments assist in athletic recovery, it is important to provide personsin need of treatment with compression garments that fit well. Thequestion of fit, or more specifically, the degree of compressionprovided by compression garments to athletes, is a common issue that hasbeen raised in the peer review process and literature regarding thevariable results. Specifically, a large majority of studies have notmeasured the exact amount of compression that study participants arereceiving. If compression is not optimized, then the garment cannotprovide effective action to an athlete, regardless of whether thatcompression can actually make any physiological difference to anathlete.

In other words, the absence of consistent scientific data showing thatcompression garments are genuinely effective for assisting athletes isconfused by the fact that compression garments that apply adequatecompression for an athlete in need of compression have not been part ofexisting study protocols. Indeed, the fit of a compression garment foruse by an athlete is critical: if compression in that athlete is notoptimized, then the garment cannot do what it is proposed to doregardless of whether that compression can actually make anyphysiological difference to an athlete. While it is possible that anoptimal degree of pressure(s) that elicits beneficial or better effectsfor athletic performance, there does not exist in the prior art a validand reliable scientific method to measure the pressure at thegarment-skin interface. While several studies reported attempts toquantify the degree of compression, these studies generally failed toreport the reliability of these measurements. Moreover, attempts tomeasure compression have occurred at a small number of easily accessiblesites that are not representative of the net compression over the entirelimb.

As with compression garments intended for use to treat edema-likeconditions, athletes can acquire custom fitted garments. The cost ofsuch “bespoke” compression garments generally likely exceeds theperceived value of the garment for most people, however, especially whencoupled with the current lack of scientifically reliable data on the useof compression garments in treating recovery after athletic activity.Moreover, as in the clinical treatment of edema-like conditions,existing methods of generating custom compression garments cannotaccurately measure the shape of a body part in need of compression alongthe entire surface thereof. This leads again back to the issue of notknowing whether compression garments are actually beneficial to athletesbecause it has been too difficult to generate compression garments thatcan, in fact, apply therapeutic amounts of compression to an athlete. Inshort, the fit of the compression garment is an important factor in howeffective such a garment will be to an athlete and without such fit, thetherapeutic effectiveness thereof will remain questionable.

Whether for therapeutic or athletic-type applications, when selectingpre-fabricated compression garments, a person is often left withinsufficient information when trying to identify the appropriatecompression garment. Such pre-fabricated garments are generally selectedusing a manufacturer's sizing chart and starting pressure levels thatare provided by manufacturers. Pressure ranges for such compressiongarments can apply to a given range of circumferences. Thiscircumference range is often large, which may make it more difficult tounderstand the compression provided by the garment, especially beyond aninitial distal measurement. An individual consumer may fit into severalsizes or have parts of his or her arm that fit into different sizes,especially with an edema-caused lobe or node or in an athlete withextensive muscle formation. As a result, the user may end up withill-fitting compression garments that, at best, provide limitedbenefits, and, at worst, can end up causing harm to the user.Nonetheless, such pre-fabricated garments remain the status quo forthose seeking lower cost and readily obtainable compression garments.

Further, even if a consumer or clinician has a compression chart withdetailed compression information for a particular compression garmentdesign, the fitting of compression garments may still be problematic. Itcan be difficult to decide upon a size and compression class that willmeet all specifications of a particular individual. For example, theremay be multiple points on a patient where the garment must meetcompression specifications. Specifications can require graduatedcompression values, meaning that compression must vary by a given amountalong the length of a limb, for example. Individuals may also havespecific characteristics, such as compression sensitivity and varyingdegrees of swelling in various limb locations, bony projections, etc.,which can create even greater complexity in the selection process. Thelocations for such body part structural variations will necessarily bespecific to the individual.

The true external shape of the body part or body area, called“morphology” herein, being fitted for compression garments will bedifficult to reproduce using the standard compression garment fittingmethod of using a tape measure. Tape measures will only identifydifferences in body part morphology to the extent that a large number ofexternal measurements are made. Since large variations in body partshape can be seen in short distances along the surface of a body part,the conventional tape measurement method cannot generate a shape for thebody part or body area being fitted. As such, many custom fittedcompression garments often do not provide the desired amount ofcompression along the whole of the body part or body area being treatedwith the compression garment. More recently, three-dimensional imagingof a body part or body area has been proposed, however, such methodshave not been found to provide clinically accurate reproductions, asdiscussed in more detail hereinafter.

Still further, certain persons may be interested in obtaining garmentsthat are specifically sized to fit their bodies. Such “custom-fit”garments have traditionally been available only from tailors orseamstresses, and have accordingly been quite expensive and thereforegenerally out of reach of the average clothing consumer. Yet further,the lack of regulated sizes in the clothing industry makes it difficultfor a person to know whether a particular garment will fit her. This notonly makes trying on clothes in a retail establishment time consumingfor shoppers, but also makes purchase of clothing online particularlychallenging.

There remains a need for improved methods of generating accurate shapeinformation for a patient's body part or body area, where such shapeinformation can be used to diagnose and monitor edema and otherconditions in a patient, as well as to provide compression therapy to anathlete. Still further, there remains a need for improvements in thefitting of compression garments for use by a specific patient in need oftreatment with compression therapy. Yet further, there remains a needfor compression garments that closely match the shape of the body partor body area being fitted with the compression garment. Yet further,there remains a need to obtain a better fit for pre-fabricatedcompression garments. The present invention provides this and otherbenefits.

SUMMARY OF THE INVENTION

Aspects of the present disclosure are related to fitting for compressiongarments via digital imaging of a wearer body part and measurement ofbody part circumferences and, optionally, lengths therefrom. In oneexample, among others, a method for selecting a pre-fabricatedcompression garment comprises selecting, by a computer or a user, awearer body part for fitting with a compression garment; acquiringdigital images of the selected wearer body part; and processing, by thecomputer, the acquired digital images, wherein the processing comprisesgenerating a first wearer fit location circumference measurement for thewearer body part at a first wearer fit location and, optionally, alength for at least part of the wearer body part. The method furthercomprises providing dimension information for a plurality ofpre-fabricated compression garments configured for the selected wearerbody part, wherein: a first circumference measurement for each of theplurality at a first garment fit location and, optionally, a garmentlength measurement is derived the dimension information; and the firstgarment fit location is at the same location on the wearer as the firstwearer fit location; comparing each of the first derived garment fitlocation circumference measurements for each of the plurality with thefirst wearer fit location circumference measurement, and, optionally,the garment length measurement with the length for the wearer body part;and identifying at least one pre-fabricated compression garment having afirst garment fit circumference measurement that is closest to the firstwearer fit location circumference measurement and, optionally, thegarment length measurement that is closest to the wearer body partlength.

In one or more aspects of the method, information associated with theidentified pre-fabricated compression garment can be provided to a user.The selected wearer body part can be at least part of an arm. The firstwearer fit location and the first garment fit location can be at or nearthe wearer's wrist. The selected wearer body part can be at least partof a leg. The first wearer fit location and the first garment fitlocation can be at or near the wearer's ankle. In various aspects, thedigital images are not acquired by rotation of an imaging device on apath about a fixed axis around the wearer or by rotation of the weareron a platform. The digital images can be acquired by an operator or adevice moving an imaging device around the selected body part or bodyarea of interest digital and an image acquisition report can bepresented on a screen that is in operational engagement with the imagecapture device, and wherein the operation of the imaging device can becontrolled remotely. A digital image acquisition report can bemonitorable by the operator or by the device substantially in real timeduring the digital image acquisition step, wherein the image acquisitionreport can include information received about a three-dimensionalreconstruction of the selected body part or body area, and wherein theoperator or the device can adjust the digital image acquisition inresponse to the received information. The compression garment can be inthe form of an arm sleeve, wherein the garment can be configured toapply a compression value to the wearer's arm of from 10 to 50 mm Hg.The compression garment can be in the form of a leg sleeve, wherein thegarment can be configured to apply a compression value to the wearer'sleg of from 10 to 50 mm Hg.

In one or more aspects, the method can further comprise generating asecond circumference measurement for the wearer body part at a secondwearer fit location; deriving from the provided dimension information asecond garment fit location circumference measurement at a secondgarment fit location for each of the plurality, wherein the secondgarment fit location is the same on the wearer as the second wearer fitlocation; comparing each of the second garment fit locationcircumference measurements with the second wearer fit locationcircumference measurement; and identifying at least one pre-fabricatedcompression garment having a second garment fit circumferencemeasurement that is closest to the second wearer fit locationcircumference measurement. In various aspects, the selected body partcan be an arm; and the second wearer fit location and the second garmentfit location can be at the wearer's wrist. The selected body part can bea leg; and the second wearer fit location and the second garment fitlocation can be the same location at or near the wearer's knee. At leasttwo or more wearer fit locations and garment fit locations can begenerated for each selected body part. Information associated with theidentified pre-fabricated compression garment can be provided to a user.The length of at least part of the body part of interest can be derivedfrom the image processing step.

Further aspects of the present disclosure are related to methods ofgenerating a shape description from digital images for a body part orbody area of interest and use of such shape description information. Thegenerated shape description information can be used to make compressiongarments specifically configured for the body part or body area.Compression garments generated from the shape description informationare also included herein.

In one aspect, among others, a method for making a compression garmentcomprises selecting a body part or body area of interest in a patient inneed of compression thereby, the body part or body area having a surfacemorphology of that patient; acquiring digital images of the selectedbody part or body area; processing the digital images by a computingdevice, wherein: the processing of the digital images comprisesgenerating shape description information for the selected body part orbody area; the generated shape description information comprisesgeometric information for the selected body part or body area, thegeometric information associated with the surface morphology of theselected body part or body area of the patient; and measurementinformation for the selected body part or body area can optionally bederived from the shape description information; providing at least onecompression value identified as therapeutically appropriate to providecompression therapy to the patient when the at least one compressionvalue is incorporated into a compression garment fabricated from theshape description information or the optional measurement information;and fabricating the compression garment from the shape descriptioninformation or the optional measurement information, wherein thefabricated compression garment incorporates the provided compressionvalue. In one or more aspects, the selected body part or body area canbe at least part of one arm or at least part of one leg. The digitalimages can be acquired by an operator moving an imaging device aroundthe selected body part or body area of interest. The imaging device canbe free to move around the selected body part or body area with sixdegrees of freedom, unconstrained by a mounting or support assembly. Invarious aspects, the digital images may not be acquired by rotation ofan imaging device on a path about a fixed axis around the patient or byrotation of the patient on a platform.

In one or more aspects, the operator can observe a digital imageacquisition report in substantially real time during the digital imageacquisition step, wherein the image acquisition report includesinformation about a three-dimensional reconstruction of the selectedbody part or body area, and wherein the operator can adjust the digitalimage acquisition in response to the received information. The digitalimage acquisition report can be presented to the operator on a screenthat is in operational engagement with the image capture device. Theselected body part or body area can comprise at least one knob or lobe,the surface morphology of the patient thereby having a complex surfacemorphology for the body part or body area. In various aspects, thecompression garment can be in the form of an arm sleeve, wherein theprovided compression value is from about 20 to about 50 mm Hg, whereinthe compression is incorporated in an area distal from a top end of thesleeve, and wherein the top end is proximal to either an elbow area or ashoulder area on the patient. The compression garment can comprisegeometric features associated with a bony area of the selected body partor body area identified by the shape description information. In someaspects, the at least one compression value comprises graduatedcompression values incorporated from a distal end of the fabricatedcompression garment.

The identified embodiments and aspects are exemplary only and aretherefore non-limiting. The details of one or more non-limitingembodiments of the invention are set forth in the accompanying drawingsand the descriptions below. Other systems, methods, features, andadvantages of the present disclosure will be or become apparent to onewith skill in the art upon examination of the following drawings anddetailed description. It is intended that all such additional systems,methods, features, and advantages be included within this description,be within the scope of the present disclosure, and be protected by theaccompanying claims. In addition, all optional and preferred featuresand modifications of the described embodiments are usable in all aspectsof the disclosure taught herein. Furthermore, the individual features ofthe dependent claims, as well as all optional and preferred features andmodifications of the described embodiments are combinable andinterchangeable with one another.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 illustrates a non-circular cross-section indicative of an arm.

FIG. 2 illustrates images of a patient with Stage 3 lymphedema on alower leg.

FIG. 3 illustrates a collection of compression garment configurationsthat can be generated with the methodology of the present invention.

FIG. 4 provides an overview of a process of the present invention.

FIG. 5 is a schematic diagram illustrating an example of a computingsystem for implementing body shape description and measurement, inaccordance with various embodiments of the present disclosure.

FIG. 6 illustrates a point cloud generated from a plurality of digitalimages of a patient's leg, where a shape description and measurementinformation can be derived therefrom.

FIG. 7 shows part of an image acquisition technique for a handheldtechnique.

FIG. 8 is a diagram of an arm showing exemplary measurement points forfitting of a compression garment.

FIG. 9 is a diagram of a leg showing exemplary measurement points forfitting of a compression garment.

FIG. 10 is a diagram illustrating an example of a process for fitting apre-fabricated compression garment for a wearer.

DETAILED DESCRIPTION OF THE INVENTION

In the following detailed description, reference is made to theaccompanying drawings, which form a part hereof, and within which areshown by way of illustration certain embodiments by which the subjectmatter of this disclosure may be practiced. It is to be understood thatother embodiments may be utilized and structural changes may be madewithout departing from the scope of the disclosure. In other words,illustrative embodiments and aspects are described below. But it will ofcourse be appreciated that in the development of any such actualembodiment, numerous implementation-specific decisions must be made toachieve the developers' specific goals, such as compliance withsystem-related and business-related constraints, which may vary from oneimplementation to another. Moreover, it will be appreciated that suchdevelopment effort might be complex and time-consuming, but wouldnevertheless be a routine undertaking for those of ordinary skill in theart having the benefit of this disclosure.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as is commonly understood by one of ordinary skillin the art to which this disclosure belongs. In the event that there isa plurality of definitions for a term herein, those in this sectionprevail unless stated otherwise.

Where ever the phrases “for example,” “such as,” “including” and thelike are used herein, the phrase “and without limitation” is understoodto follow unless explicitly stated otherwise.

The terms “comprising” and “including” and “involving” (and similarly“comprises” and “includes” and “involves”) are used interchangeably andmean the same thing. Specifically, each of the terms is definedconsistent with the common United States patent law definition of“comprising” and is therefore interpreted to be an open term meaning “atleast the following” and is also interpreted not to exclude additionalfeatures, limitations, aspects, etc.

The term “consisting essentially of” is meant to exclude any featuresthat would change the basic and novel characteristics of the presentinvention, as claimed.

The term “about” is meant to account for variations due to experimentalerror. All measurements or numbers are implicitly understood to bemodified by the word about, even if the measurement or number is notexplicitly modified by the word about.

The term “substantially” (or alternatively “effectively”) is meant topermit deviations from the descriptive term that don't negatively impactthe intended purpose. Descriptive terms are implicitly understood to bemodified by the word substantially, even if the term is not explicitlymodified by the word substantially.

“Edema” is the accumulation of excess fluid in a fluid compartment. Thisaccumulation can occur in the cells (i.e., cellular edema), in theintercellular spaces within tissue (i.e., interstitial edema), or inother spaces in the body. Edema can be caused by a variety of factors,including indications associated with osmotic pressure, such asashypotonic fluid overload, which allows the movement of water into theintracellular space, or hypoproteinemia, which decreases theconcentration of plasma proteins and permits the passage of fluid out ofthe blood vessels in to the tissue spaces. Other factors can includepoor lymphatic drainage (known as “lymphedema”), conditions associatedwith an increased capillary pressure (e.g., excessive retention of saltand/or water), heart failure, and conditions associated with increasedcapillary pressure, such as inflammation (e.g., burns or other trauma).

As used herein, the phrase “detecting edema” or “diagnosing edema” meansdetecting or diagnosing the existence of edema, as well as the onset ofedema, early stage edema and the progression of edema over time. Thus,methods for detecting edema can also be used to monitor the progressionof edema over time and treat/manage edema in an individual.

The term “lymphedema” may include either primary or secondarylymphedema, the latter of which might also be term “acquired”lymphedema. Some forms of lymphedema can occur in morbidly obesepatients, such as the condition known clinically as “Massively LocalizedLymphedema.” Lymphedema is a category of edema, although it is alsocharacterized as a separately treatable indication, such as when it is acomplication of breast cancer treatments in which lymph activity inpatients is affected. As would be recognized, primary lymphedema iscaused by abnormal development of the lymph system. Symptoms can bepresent at birth, or may appear later in life. Secondary lymphedema iscaused by damage to the lymphatic system. The lymphatic system may bedisrupted, damaged or blocked by infection, injury, cancer, removal oflymph nodes, radiation to the affected area or scar tissue fromradiation therapy or surgery. In some aspects, the present inventionprovides methods of detection of lymphedema that occurs as a result ofremoval or damage to lymph nodes that occurs after treatment of apatient for breast cancer.

“Post-recovery compression treatment” means the application ofcompression therapy via wearing of a garment providing one or morecompression values to at least one area on a person after an exerciseevent. The types of exercise events are expansive and can, for example,include running/jogging/walking, weight lifting, swimming, participationin team sports (e.g., football, basketball, soccer, baseball), and thelike.

“Compression garment” as used herein means garments that are constructedfrom elastic material and that are intended to apply pressure whenstretched over the skin while being worn. Compression garments are wornover an area of the body where a therapeutic response (e.g., fortreatment of lymphedema or swelling post-surgery etc.) or, when used insports-related applications, for post-recovery compression treatment forenhanced recovery of a person after an athletic event. Typically,compression garments comprise one or more compression values that, whenworn by a patient in need of treatment, are configured to apply anintended or prescribed level of compression therapy to the patient. Whena person is wearing compression garments that are properly sized andfitted for that person's limb, trunk or extremity, etc., such garmentsapply a pressure to the skin that is generally dependent on both thematerial construction and the size and the shape of the garment, and howwell the garment conforms to the unique aspects of the wearer's shape.An intended or prescribed level of compression therapy for a patient inneed of treatment is the selection of one or more compression values tobe applied to the patient during the wearing of a compression garment.

“Anthropometry” means the measurement of the size and proportions of thehuman body. “Anthropometric measurements” are measurements that compriseinformation regarding the contour, volume, overall size and otherrelevant information, where such information has relevance to thefitting of garments that are specifically sized for a person in need offitting for such garments.

In broad constructs, the present invention provides advancements ingeneration of mathematically accurate information about the shape of abody part or body area in a person or, if in a medical context, apatient. A patient can be a human or an animal. In some aspects, theinventive methodologies herein provide improvements in the ability todetect edema and other conditions associated with swelling of a bodypart or body part area, as well as being useful in generatingcompression garments from such mathematically accurate information,where such compression garments are derived from imaging of such bodypart or body part areas.

The inventive enhancements can be attributed to, at least in part, theincorporation of shape description techniques to derive accuratenumerical information about the shape of the body part or body area ofinterest in a three-dimensional coordinate system, wherein shapecomprises geometric—that is, numerically based—information that isinvariant to translation, rotation, and scaling.

Such numerically based shape information is to be distinguished fromprior art imaging techniques for body part and body areas where a shaperepresentation is derived therefrom. Shape representation methods resultin a non-numeric representation of the original shape (e.g., a graphicalrepresentation), where certain aspects of the shape are preserved, sothat the shape can be processed from that representation. Accurategeometry—that is, mathematical information—is not directly derivablefrom a shape representation. In other words, the measurements of thesubject object, such as a body part or body area in the presentinvention, can only be approximated or determined indirectly by using areference scale using shape representation methodology. Suchmeasurements require generation of an accurate and scale invariantreference scale in order to have utility.

In contrast, a shape description results from a processing stepsubsequent to shape representation, whereby the unique aspects of theshape of the object in the image can be derived accurately ingeometric/numerical form. In this regard, accurate numerical informationabout one or more unique features of the shape of interest—here a bodypart or body part area—are derivable from the plurality of acquireddigital images.

Specifically, in the context of the enhancements possible with thepresent methodology, a person or patient's unique body part or body areasurface morphology characteristics are derivable herein. Such surfacemorphologies are provided by the generation of a shape description forthe selected body part or body part area that are derived from shapeanalysis techniques known to those of skill in the art.

In one aspect, the Laplace-Beltrami equation:

${{\Delta u} \equiv {{\frac{\partial}{\partial\xi}\left( \frac{{F\frac{\partial u}{\partial\eta}} - {G\frac{\partial u}{\partial\xi}}}{\sqrt{{EG} - F^{2}}} \right)} + {\frac{\partial}{\partial\eta}\left( \frac{{F\frac{\partial u}{\partial\xi}} - {E\frac{\partial u}{\partial\eta}}}{\sqrt{{EG} - F^{2}}} \right)}}} = 0.$can be used to resolve the shapes of the body part or body area ofinterest. Still further, Fourier Descriptors or Turning Functions can beused as discussed in R. C. Gonzalez and R. E. Woods, Digital ImageProcessing, Englewood Cliffs, N.J.: Prentice Hall, 2007, and Volotão,Carlos F S, et al., “Shape characterization with turning functions,”Proceedings of the 17th international conference on systems, signals andimage processing, Editora da Universidade Federal Fluminense, Vol. 1,2010, respectively. Still further, the alpha-shape family of algorithms,as first introduced in H. Edelsbrunner, D. G. Kirckpatrick, and R.Seidel, “On the shape of a set of points in a plane,” IEEE Transactionson Information Theory. Vol. 29, Issue 4, 1983, which is derived from theDelaunay Triangulation, can be used to define shape and shape boundariesin two and three dimensions, for example such that the boundary isdefined as ∂S_(α)={Δ_(T)⊂S, |T|≤d, and Δ_(T) is α−exposed}. Thedisclosures of these references are incorporated herein in theirentireties by this reference.

The inventive methodology can generate shape description informationabout one or a plurality of patient areas along a body part or bodyareas, such as all or part of a leg, an arm, neck, torso etc., wheresuch shape description information can be utilized in assessing theamount of swelling on a specific person on a longitudinal basis, such asfrom day to day, week to week, month to month, and year to year, forexample.

In their work with patients symptomatic of edema, the inventors hereinhave determined that existing three-dimensional digital imaging of bodypart and body areas for analysis, while generating depth maps and theassociated point clouds for analysis, nonetheless do not providesuitably accurate clinical results. All of the reviewed prior artimaging methodology intentionally reduce the complexity of the generatedpoint clouds so as to generate measurements of the body part or bodyarea of interest. For example, Isobar Compression, a company thatgenerates compression garments from digital imaging (seehttp://www.isobar-compression.com/) specifically refers to down-samplingthe point cloud to generate transverse cross-sectional measurements withlimited metric extraction (circumference, radius of curvature, etc.).Said differently, all prior art methods known to the inventors hereindiscretizes the point cloud to provide simple one and two-dimensionalmeasurements.

The reason for all prior art simplifying the measurement process isbelieved by the inventors herein to: (1) address the mathematicalcomplexity involved in generating more advanced geometric information(i.e., it is not a trivial step to progress from simple one or twodimensional cross-sectional measurements to detailed shape descriptionin 3 dimensions); and (2) a lack of knowledge of the need and value ofgeometric analysis in diagnosing conditions and/or designing garmentsfor patients in need of treatment with compression therapy, as providedby the inventors herein.

As to the latter, the inventors herein have discovered that accuratediagnosis and monitoring of edema-like conditions can be enhanced withuse of the methodology herein. Yet further, the inventors have foundthat determination of the sizing and fit of compression garments—bothcustom and pre-fabricated—can be greatly improved by generation ofthree-dimensional geometric information from the digital images by wayof the generated point clouds.

Moreover, the inventive image acquisition processes suitably generatepoint cloud information that is optimizable to generate geometricinformation that is relevant to patients with edema and similarconditions, which is a specific clinical insight of the inventorsherein.

The quality of prior art body part or body area measurement informationwas also believed constrained by the use of a discrete set of elementsassociated with the body part or body area of interest, namely, length,circumference at defined intervals, which were used to generatemeasurement information that could not resolve the unique surfacemorphological features associable with a specific patient's body part orbody area. Such prior art measurement techniques have been found by theinventors herein to not allow the generation of fully accurate,geometrically-based, 3D representations of a patient's body part or bodypart area, at least in regard to unique surface morphologies for thatpatient. This, in turn, was found to limit the diagnostic andtherapeutic effectiveness of the measurement information so obtained.

Prior art methodology generally uses a series of “stacked”cross-sections to represent a limb, for example, as cross-sectional“slices” provided in a defined thickness interval (e.g., mm, cm, etc.)Using these prior art models, the geometry of a limb, for example, istherefore only understood in a series of transverse sections, that are“generically” reconstructed to provide information substantially withoutcharacterization of unique morphological features of that patient. Theinventors herein have determined after extensive analysis that suchprior art methodologies do not comprise enough information about thesubject body part or body part area for some relevant use cases.

In some aspects, the inventive methodology includes axial measurementsto generate the shape description, and associated information. Suchaxial measurements can be in the form of surface lines substantiallyspanning the length of the patient body part or body area of interest.Such surface lines can be spaced at a degree Θ around the body part orbody area of interest. The inventive methodology can therefore beconducted in multiple planes and in multiple dimensions to allowacquisition of a shape description which, in turn, results in higherquality measurement information for analysis and use.

As an illustrative example, consider a patient who exhibits swelling onthe outer side of her forearm. Using a prior art methodology, avolume-based measurement (that is, methodology that considers armgeometry to be an approximation of a cylinder) would indicate that thereis swelling in the forearm, but information about the precise locationof such swelling would be absent. Analysis of circumference measurementscould indicate that swelling was occurring in the forearm, but not whichside of the forearm the swelling was presenting. Radius of curvatureinformation could indicate that the forearm has more of less curvaturealong the length thereof, but information about the precise degree ofcurvature would be lacking. Circumference would indicate that forearmswelling has gone down and upper arm swelling has gone up but noinformation about which side of the arm the swelling was presenting.

In contrast, shape description and the mathematically accurateinformation derivable therefrom, such as provided with the inventivemethodology, can provide a markedly higher degree of detail as to theexact location of swelling on the forearm on a specific patient, as wellas the size thereof. The present invention allows the unique surfacemorphology of a specific patient to be resolved from digital imaging ofa body part or body area on that person. Shape description andassociated mathematically accurate information derivable from digitalimaging conducted over time can also provide the exact degree to whichthe shape characteristics of this patient's forearm and on her upper armhave changed, which would further inform ongoing treatment of thispatient and to allow compression garments fitted to the specificmorphological characteristics of this patient to be appropriatelyfabricated. In this regard, the inventive methodology has been found togenerate enhanced geometric information about the forearm and anymorphologies thereon, such as the “bump” indicated by swelling. In otherwords, the use of shape description allows one to determine not onlythat the bump is present and its size on this patient, but also wherethe bump is positioned in three-dimensional space, which is determinedbased upon shape description of the surface boundary.

In further aspects, the enhanced measurement information derived from animaged body part or body part area has been found to enable improveddiagnosis and monitoring capability, as well as allowing generation oftherapeutic direction for that patient. Such enhanced information hasbeen found to be highly relevant to understanding changes in theswelling of a specific patient's limb or a body part over a time period,and to generate a well-fitting compression garment that suitably appliesa prescribed level of compression therapy.

Turning back to the example of the patient with a bump on her forearm, aprescribed therapy, such as massage therapy, could result in the bumpmoving to another location on her arm, perhaps as far away as the upperarm. Without use of the inventive technique that applies shapedescription to generate precise information about the surface morphologyof the specific patient at each imaging event from which shapedescription information is obtained, knowledge about the effectiveness(or lack thereof) of the prescribed treatment would be lacking if theimaging technique only reported a volume measurement, as is the casewith prior art measurement techniques. This would be an incorrectclinical determination. In contrast, the inventive information derivedfrom shape description techniques would instead return detail about notonly about the movement of the swelling within the arm, but also itssize and location on the arm, thus allowing, among other things, aclinical assessment that takes into consideration the effect of theprescribed treatment, massage therapy in this example. This can allow aclinician or other medical provider to generate a treatment plan basedon actual knowledge of the effects of an applied treatment, includingcompression therapy as discussed elsewhere herein.

It has been found that a first highly accurate three-dimensionaldepiction of a patient's specific body part or body area shape ormorphology, such as is possible with the shape descriptions herein, canserve as a baseline for monitoring of subsequent changes in that samebody part or body area morphology, thereby providing predictive insightas to ongoing symptoms of a patient with actual or potential edema.

It has also been found that information about a specific patient'ssurface morphology as is derivable with shape descriptions for a bodypart or body part area can be especially useful when generatinginformation in patients having complex surface morphologies, such asthose with nodes or lobes on their body surfaces, for example, as occurswith people with high levels of edema and/or who might be morbidlyobese. Further, such surface morphology information has been found to beuseful in the selection of compression therapy and associated garmentsfor post-exercise recovery.

Notably, people who are symptomatic of edema may also be obese. Patientswith complex surface morphologies are often the hardest patients todiagnose for edema and similar conditions due to their highly irregularbody part or body area shapes. When using prior art imagingmethodologies in the detection of the potential progression of edema,the complex surface morphologies of such patients have been found togreatly reduce the effectiveness of detection. Acquisition of geometricinformation associated with the specific patient's body part or bodyarea of interest is possible with generation of a surface descriptionthat can be used to generate measurement information for the patient'sbody part or body area of interest has been found to greatly improve thequality of clinical information available for that patient.

With the present invention, diagnosis and monitoring ability is improvedover prior art imaging methodology for at least these patients.Moreover, the ability to generate well-fitting compression garments orto enhance the selection of pre-fabricated garments that are intended todeliver a prescribed one or more compression values to a patient havingcomplex surface morphologies is greatly enhanced, at least because theprovided garment is custom generated for or selected to fit the specificbody part or body area of that patient, even in view of her non-uniformskin surface configuration.

Beyond the specific subset of patients having complex surfacemorphologies, the inventors herein have determined that measurement ofbody parts or body areas using the standard tape measure technique orprior art imaging methodology cannot suitably generate a compressiongarment fit that substantially conforms to the shape of the patient'sbody part that is in need of compression treatment as is indicated by acompression prescription generated by a provider or as needed by anathlete for post-exercise recovery. In this regard, it has beendetermined that circumference measurements taken by the tape measurementtechnique do not provide accurate information about the shape of theparts, and subparts, of the body regions being measured for fitting withcompression garments. Moreover, prior art imaging techniques areconfigured to extract the circumferences of the body parts or body areasof interest. When a body part or body area are assumed to be a circle,which is the case with measurements of body parts or body areas takenaccording to these prior art methods, a circle, an ellipse, and a squaremay each demonstrate the same “circumference,” but, as would berecognized, would present markedly different shapes.

Prior art compression garments generated from measurements for thepreparation of custom compression garments or for selection ofpre-fabricated compression garments using to the prior art methodologyare fitted according to the premise that the body part being fittedessentially has a circular cross section, even while the person's arm orleg (or other body part) may, in fact, deviate substantially from acircle along the length thereof. The inventors have determined that theflawed assumption of a circular cross-section can, in turn, distort thepressure applied to the body part to which compression therapy is beingapplied. Such distorted pressure will result in a deviation in all orpart of the intended compression values and compression gradients beingapplied to the body part by the compression garment. Accordingly, thecompression effectiveness of the compression garment generated from onlya plurality of circumferential and length measurements taken by a tapemeasure when the patient's body part being treated with compressiondeviates from the assumed cylindrical cross section. FIG. 1 shows anexample of a non-circular cross-section of an arm.

With specific reference to prior art three-dimensional digital imagingof body part and body areas for analysis of lymphedema, all such digitalimaging methods reviewed by the inventors herein generate point cloudsfor analysis. However, all of these prior art methods intentionallyreduce the complexity of the point cloud in order to extractmeasurements of the body part or body area of interest. For example,Isobar Compression, a company that generates compression garments fromdigital imaging (see http://www.isobar-compression.com/) specificallyrefers to down-sampling the point cloud to generate transversecross-sectional measurements with limited metric extraction(circumference, radius of curvature, etc.). Said differently, allreviewed prior art discretizes the point cloud to simple one andtwo-dimensional measurements.

Further with regard to the clinical realization, the inventors hereinhave discovered that accurate diagnosis and monitoring of edema, andother conditions, as well as the sizing and fit of compression garmentsspecifically configured for the person such as an athlete in need ofpost-exercise compression therapy, can be greatly improved by generationof three-dimensional geometric information from the digital images byway of the generated point clouds. Moreover, the inventive imageacquisition processes suitably generate point cloud information that isoptimizable to generate geometric information that is relevant topatients with edema and similar conditions, which is a specific clinicalinsight of the inventors herein.

Yet further, the use of shape description information that is highlyaccurate as to a specific person has been determined by the inventorsherein to allow the addition of features such as mobility regions forelbows and knees that, when included in a compression garment derivedfrom such measurement information, has been found to improve fit andpatient compliance. In this regard, areas of the patient having specificmorphological characteristics (e.g., curves, bends, sharpness, etc.) canbe substantially identified and incorporated into shape descriptions andassociated information according to the methodology herein, and acompression garment generated that is substantially matched to thepatient's precise surface morphology can be generated. Incorporation ofsuch patient specific surface morphology into a compression garment,such as geometric features associated with bony areas on the patient'selbow, can reduce the propensity of the compression garment to causefriction sores on the patient during wearing thereof, for example. Inaddition, the compression garment can include non-compressive materialsor openings at bony areas or joints to reduce or eliminate pain,irritation or restriction of movement. These can be identified by themorphological characteristics of the shape descriptions.

Moreover, the inventors herein have found that with better fittingcompression garments and compression garments having shapes that moreclosely match those of the body part or body area of interest, resultantpressures applied from the garment will be much closer to the pressureprescribed by the clinicians, which is expected to result inimprovements in therapeutic outcomes. For example, a clinical conditionof “massively localized lymphedema,” is occurring in greater frequencyin persons who are morbidly obese. Such patients typical presentclinically with a large fold or lobe extending from an upper area of thethigh to extend typically down to the knee area Compression therapy isoften indicated for such patients, however, the complex surfacemorphology results in a difficult fitting procedure that can result in acompression garment that likely only approximates the shape of thepatient area being treated. Using the imaging methodology of the presentinvention, digital images can be processed to derive a shape descriptionof the patient's body part or body area—here the patient's upper legregion—which can be rendered into measurement information thatsubstantially matches the unique surface morphology of the patient tothereby allow highly customized compression garments to be obtained.Such processing incorporates a step of “stitching” or “fusing” of thedigital images together, so as to derive the shape description. FIG. 2shows a further example of a complex patient surface morphologyresulting from a lower leg stage 3 lymphedema presentation.

In further aspects, the methodology herein allows compression garmentsto be generated, wherein the compression garments are substantiallymatched to the surface morphology of an individual person, in otherwords, the garments are customized for the person in need of compressiontherapy. As would be recognized, compression therapy is indicated forconditions involving venous and lymphatic insufficiency in the lowerlimbs, including varicosities, lymphedema, venous eczema and ulceration,burn treatments, deep vein thrombosis and post-thrombotic syndrome,among others. A person, for example, a patient with actual or potentialsymptoms of edema or the like, can be imaged along at least part of onebody part or body part area of interest to generate digital images ofthe body part or body area of interest that can be rendered into shapedescriptions and associated information derivable therefrom that issubstantially matched to the specific patient's body part or body partarea.

Compression garment fit parameters are defined for a patient by aprovider or using prescribed compression information, Compressiongarments are configured to apply more pressure distally while graduallydecreasing pressure as the garment travels up the extremity. Compressionhelps encourage and facilitate fluid movement for patients affected bylymphatic and venous disorders. With appropriate compressionapplication, vessels in the circulatory and lymphatic systems can absorbmore fluid from tissues. The result is increased absorption of tissuefluid and decreased swelling.

Compression garments can be indicated for the lower extremities in theform of leg stockings, such as disclosed in US Patent ApplicationPublication No. 20150051524, the disclosure of which is incorporatedherein in its entirety by this reference. The '524 Publication disclosescompression stockings in which compressions for therapeutic effect areincorporated therein. Such compression garments can be generated frominformation obtained according to the inventive methodology herein.Compression garments having prescribed compression values therein canalso be indicated for the upper body and arms in the form of compressionsleeves for the arm, worn with or without a hand component (e.g.,fingerless glove or a gauntlet that does not have individual finderopenings), or a support bra for the chest area or a vest for the entiretrunk area.

A variety of compression garment configurations are derivable from themethodologies herein. Such configurations include, but are not limitedto those illustrated in FIG. 3 . Other variations can also be generated,as indicated by the patient's medical condition or post-exerciserecovery need. In order to suitably generate such compression garmentshaving a prescribed or indicated compression prescription incorporatedtherein for a patient in need of treatment, the methodology herein canbe used to obtain measurement information derived from shapedescriptions generated from imaging of the body part or body area ofinterest as discussed further herein. Fabrication instructions can begenerated from such measurement information. Still further, generatedshape descriptions can be used to generate suitable fabricationinstructions.

TABLE 1 TYPES OF COMPRESSION GARMENTS A- knee high stocking one leg B-thigh high stocking One leg C- full leg stocking chap style one leg D-full leg stocking with brief one leg (open crotch shown, but also can beclosed crotch) E- full leg stockings two legs (open crotch shown, butalso can be closed crotch) F- chest high stockings for pregnancy twolegs G- panty girdle (above knee shown, but can also be below knee) H-one leg open crotch with high leg brief I- stump stocking (below kneeshown, but also can be above knee) J- torso shirt (no sleeves shown, butcan also have sleeves) K- two arm half shirt (two arms shown, but canalso be one arm) L- short bodysuit (no sleeves shown, but can also bewith one or two sleeves) M- long bodysuit (sleeves shown but can be nosleeves) N- wrist to axilla gauntlet O- metacarpals to axilla gauntletand glove P- wrist through shoulder flap gauntlet Q- metacarpals throughshoulder flap gauntlet and glove R- metacarpals to wrist glove S-fingers to axilla gauntlet and glove T- fingers to wrist glove U- wristto elbow glove V- elbow to wrist glove W- metacarpals to elbow gauntletX- full face and neck mask Y- head and neck cover

As would be understood, compression garments must be properly fitted toachieve the therapeutic results in patients where treatment isclinically indicated or where post-exercise recovery is relevant. In thecontext of compression therapy in the arm region, at a minimum, animproperly fitted sleeve can reduce the application effectiveness ofcompression therapy by inadequately applying the prescribed compressions to the patient's arm. Moreover, an improperly fitted sleeve can makeconditions such as lymphedema worse by placing too much or too littlepressure on certain areas of the body part or body part area, which cancause fluid backup to worsen. The specific external pressure applied tothe body part or body area can also exert a massaging effect on the bodypart or body area to enhance the therapeutic action of a compressiongarment.

The inventors herein have found that prior art measurementinformation—whether derived from measuring the patient directly such asby a tape measure or that is derived from prior art image acquisitiontechniques—used to generate custom fitted compression garments do notadequately take into account the unique shapes, that is, surfacemorphologies of each patient. In this regard, the inventors havedetermined body part or body area shape description and informationderivable therefrom that is derived from shape descriptions obtainedfrom imaging can greatly improve the fit, and therefore, therapeuticefficacy of one or more prescribed compression values in patients inneed of compression therapy. Moreover, such shape descriptions andassociated derivable information is particularly useful in persons withcomplex body morphologies, such in people having lobes or folds alongthe body part or body part area where compression therapy is indicated.Still further, such shape description information can be used togenerate fit information for a person in the selection ofpre-fabricated—that is, ready-to-wear or off-the-shelf—compressiongarments as discussed in more detail hereinafter.

In some aspects, the present invention comprises obtaining at least onecompression value prescribed for a patient from a provider. Suchprescription will include at least an identification of the body part orbody part area upon which the compression therapy is to be applied via acompression garment and one or more compression levels to beincorporated into the compression garment for use.

Compression values to be applied to a person are typically expressed inmm of mercury (Hg), where such units are in relation to the pressureapplied by the pressure garment when worn by a patient. Compressionvalues that may be generated for incorporation into compression garmentsaccording to the methodology herein are presented in Table 2:

TABLE 2 SAMPLE COMPRESSION VALUES 10-30 mm Hg Post-exercise recovery20-30 mm Hg Mild varicose veins; arterial insufficiency with venousinsufficiency 22-28 mm Hg Burns-prevention of hypertrophic scars 30-40mm Hg Moderate varicose veins; assist fluid return; leg fatigue; stasisdermatitis; post-phlebitic syndrome; post-surgical stripping ofsclerosing; post-fracture edema; prophylactic treatment of edema andphlebitis; moderate lymphedema 40-50 mm Hg Chronic venous insufficiency;severe stasis dermatitis; severe lymphedema; severe chronic venousinsufficiency; moderate orthostatic hypotension 50-60 mm Hg Severeorthostatic hypotension, severe post-thrombosis; intractable edema

The generated compression value information, such as, but not limited tothe ranges set out in Table 2, can be incorporated into compressiongarment manufacturing processes discussed hereinafter.

As noted previously, the methodology herein can be used to monitor theprogression or regression of edema and other conditions in a patient. Togenerate more accurate detection or diagnosis of the occurrence of edemain a patient in need of detection or diagnosis, a baseline body part orbody part area shape description is obtained after acquisition of aplurality of digital images of a body part or body area of interest fora patient. The shape description and/or any geometric informationtherein or any measurement information derivable therefrom can becompared to subsequent shape description(s) and associated informationacquired for that patient to determine whether edema or other conditionshave changed for the patient over time. Subsequent digital imageacquisitions can be performed at intervals concordant with the medicalpractitioner's standard of care. In some aspects, the subsequent imageacquisitions can be conducted on a daily, weekly or monthly basis. Themethodology herein is suitable for addressing potential or actual edemaof one or more of the upper extremity, lower extremity, head or neck,chest, head or genital areas, as non-limiting examples.

In further aspects, the methods herein can enhance patient access toregular body part or body area examination for the appearance ofedema-related symptoms because the imaging processes herein aresimple-to-use in that the image acquisition steps can suitably beoperated by only minimally trained individuals, as long as highresolution images including clinically accurate information, that is,shape descriptions, geometric information, and/or measurementinformation derived therefrom, of the body part or body area ofinterest. As such, the methodology herein can allow more frequentpatient monitoring than is normally possible with existing edemadetection and monitoring methodologies. In some aspects, the patientimage acquisition step can occur in a location remote from the patient'smedical team. For example, the patient imaging step can be conducted inthe patient's home or other non-clinical setting.

Imaging devices suitable for use in the present invention can compriseany device suitable for generating digital images from which a shapedescription of the body part or body area can be derived therefrom. Onesuch device is the Kinect 2® device from Microsoft Corporation, whichprovides depth maps from the imaging process. Another suitable device isthe Structure IO® system that combines a sensor engageable with an iPad®or other mobile device to generate digital images that can be processedto generate suitably detailed numerical information about the body partor body area of interest for use herein. Still further, imaging devicesthat will increasingly be incorporated into mobile devices can also beused to generate images from which shape descriptions can be generated.The Lenovo Phab2 Pro® is an early example of one of these devices.

The imaging devices can be configurable to generate point cloudsdirectly from the imaging step. In some aspects, the imaging acquisitionstep can be configured to generate as many depth maps as is required ina particular image acquisition process to be able to generate a suitablyinformation dense final point cloud from which a shape description canbe derived therefrom. As an example, one could capture one depth map atevery degree of rotation around a leg of a patient and the process canbe repeated the process at three different heights, which would generate1,080 depth maps that are used to generate the point cloud. The numberof depth maps derivable from the imaging process is dependent, at leastin part, by the frame rate of the capture device and the ability toprocess a suitable amount of data. The ability to generate a shapedescription from an imaging step, and the associated geometric andmeasurement information, is highly influenced by the density of thegenerated point cloud. For example, a point cloud suitable forgenerating a shape description for an average leg has about 50,000unique data points in the point cloud.

To suitably obtain the requisite point cloud data from the imageacquisition step, the image capture device can be operationally engagedwith a device upon which the image acquisition process can be reviewedsubstantially in real-time during acquisition of the plurality ofimages. In this regard, the image capture device is in operational andcommunications engagement with a second device, where the second devicehas a screen that can be reviewed by the person, or operator, who isoperating the image capture device. Alternatively, a second person, oroperator, can be reviewing the image acquisition substantially in realtime, to provide instructions to the first operator where to direct theimage capture device so as to acquire suitable images for use herein. Insome aspects, either or both of the first or second operators can be aperson. In separate aspects, the either or both of the first or secondoperators can be a computer or other computing device. If either or bothof the first or second operators are computers, at least some of theimage acquisition process can be partially or fully automated. Stillfurther, image processing, and any associated image analysis stepconfigurable to provide an edema or other diagnosis, can be by either orboth of a person or a computing device, thereby providing full orpartial automation thereof.

In some aspects, while the plurality of digital images are beingacquired, an operator can review an image acquisition report, such as onthe screen. The operator can then adjust the image acquisition processby acquiring one or more images to address any deficiencies notable inthe report, such as holes, seams, etc. in the acquired depth map, forexample. The image acquisition report can also provide written or spokeninstructions to the operator such as, “get closer to the inner thigh andacquire more images,” for example.

Wireless communications are well-suited to allow enhanced flexibility inimage acquisition. For example, in the handheld method discussedhereinafter, the operator freely rotates the image capture device aroundthe selected body part or body area of interest. With wirelesscommunications engagement between the image capture device and a remotecomputing device to which the acquired digital images can betransmitted, image acquisition flexibility can be enhanced. Suchwireless communication capability between the image capture device andany associated computing devices can be by one or more of W-Fi,Bluetooth®, RFID, cellular or the like. As would be recognized, someimage capture devices will be integrated with a mobile device (e.g.,smartphone, tablet, etc.), with the mobile device suitably being inwireless communication with a remote computing device. The mobile devicecan also be a computing device.

Referring to FIG. 4 , a process 400 according to the present inventionis illustrated. In a first step 405, a body part of or body area of apatient in need of treatment is selected or designated for imaging. Instep 410, digital imaging of the selected body part or body area isperformed, which can be rendered on a screen viewable by the operator inthe form of a depth map. Such acquired images can be processed in 415 togenerate a shape description—that is geometric information—of theselected body part or body area. In step 420, the shape description canbe used in the diagnosis of edema, etc., such as to determine a first(or baseline) amount of edema, etc. in the patient or to generatemeasurement information to be used in the selection of pre-fabricatedcompression garments. Alternatively or, optionally, in addition to step420, in 425 compression garments can be generated that are specificallyconfigured for the body part or body area, to be worn on the body partor body part area at 430. A monitoring step 435 incorporates additionalimage acquisition 410 etc. for the previously selected and imaged bodypart or body area. If the generated compression garment is worn in 430,monitoring step 435 can occur to assess whether wearing such compressiongarment in step 430 results in an improvement or a change in a firstamount of the edema, etc., that was diagnosed in 420. Still further,monitoring step 435 can be used to determine whether the wearing of suchcompression garment in step 430 results in an enhanced post-exerciserecovery for an athlete.

In a further aspect, the inventive methods of the present inventioncomprise acquiring digital images of a body part or body area ofinterest using a four-sided imaging technique as disclosed in US PatentApplication Publication No US20160235354, the disclosure of which isincorporated in its entirety by this reference. When digital images areacquired according to the methodology in the '354 Publication, shapedescriptions and measurement information suitable for the diagnosis andmonitoring of edema and other conditions can be obtained. Moreover,compression garments specifically configured for the patient can befabricated from instructions derived from the shape descriptions ormeasurement information. To summarize the image acquisition methodologyin the '354 Publication, generally:

-   -   a. The patient is positioned about 3-5 feet from a Kinect 2®, or        any other suitable imaging device/computing device/software        configuration, where the imaging device is positioned about 2-4        feet from the floor on a platform. The height of the imaging        device is dependent, in part, of whether the upper or lower or        all of the patient's body is being imaged.    -   b. A plurality of digital images, for example about 2 to about        20, are taken of each of the patient's front side, first side,        back side, and second side of the body part or body area. If the        arms are being imaged, the patient can be instructed to hold her        arms at about 90 to about 60 degrees from her side. If the legs        are being imaged, the patient can be instructed for image        acquisition to position her legs as far apart as possible, for        example to allow a gap between her thighs to be visible.    -   c. Once the images are acquired they can be processed to        generate a shape representation of the patient body part or body        area as discussed further herein.

With reference to FIG. 5 , shown is a schematic block diagram of acomputing device 500, In some embodiments, among others, the computingdevice 500 may represent a mobile device (e.g., a smartphone, tablet,computer, etc.). Each computing device 500 includes at least oneprocessor circuit, for example, having a processor 503 and a memory 506,both of which are coupled to a local interface 509. To this end, eachcomputing device 500 may comprise, for example, at least one servercomputer or like device, which can be utilized in a cloud basedenvironment. The local interface 509 may comprise, for example, a databus with an accompanying address/control bus or other bus structure ascan be appreciated.

In some embodiments, the computing device 500 can include one or morenetwork/communication interfaces 510. The network/communicationinterfaces 510 may comprise, for example, a wireless transmitter, awireless transceiver, and/or a wireless receiver. As discussed above,the network interface 510 can communicate to a remote computing deviceusing a Bluetooth, WiFi, or other appropriate wireless protocol. As oneskilled in the art can appreciate, other wireless protocols may be usedin the various embodiments of the present disclosure. In addition, thecomputing device 500 can be in communication with one or more imagecapture device(s) 521. In some implementations, an image capture device521 can be incorporated in the computing device 500 and can interfacethrough the locate interface 509.

Stored in the memory 506 are both data and several components that areexecutable by the processor 503. In particular, stored in the memory 506and executable by the processor 503 can be a body shape descriptionprogram 515 and potentially other application program(s) 518. Alsostored in the memory 506 may be a data store 512 and other data. Inaddition, an operating system may be stored in the memory 506 andexecutable by the processor 503.

It is understood that there may be other applications that are stored inthe memory 506 and are executable by the processor 503 as can beappreciated. Where any component discussed herein is implemented in theform of software, any one of a number of programming languages may beemployed such as, for example, C, C++, C#, Objective C, Java®,JavaScript®, Perl, PHP, Visual Basic®, Python®, Ruby, Flash®, or otherprogramming languages.

A number of software components are stored in the memory 506 and areexecutable by the processor 503. In this respect, the term “executable”means a program file that is in a form that can ultimately be run by theprocessor 503. Examples of executable programs may be, for example, acompiled program that can be translated into machine code in a formatthat can be loaded into a random access portion of the memory 506 andrun by the processor 503, source code that may be expressed in properformat such as object code that is capable of being loaded into a randomaccess portion of the memory 506 and executed by the processor 503, orsource code that may be interpreted by another executable program togenerate instructions in a random access portion of the memory 506 to beexecuted by the processor 503, etc. An executable program may be storedin any portion or component of the memory 506 including, for example,random access memory (RAM), read-only memory (ROM), hard drive,solid-state drive, USB flash drive, memory card, optical disc such ascompact disc (CD) or digital versatile disc (DVD), floppy disk, magnetictape, holographic storage, or other memory components.

The memory 506 is defined herein as including both volatile andnonvolatile memory and data storage components. Volatile components arethose that do not retain data values upon loss of power. Nonvolatilecomponents are those that retain data upon a loss of power. Thus, thememory 506 may comprise, for example, random access memory (RAM),read-only memory (ROM), hard disk drives, solid-state drives, USB flashdrives, memory cards accessed via a memory card reader, floppy disksaccessed via an associated floppy disk drive, optical discs accessed viaan optical disc drive, magnetic tapes accessed via an appropriate tapedrive, and/or other memory components, or a combination of any two ormore of these memory components. In addition, the RAM may comprise, forexample, static random access memory (SRAM), dynamic random accessmemory (DRAM), or magnetic random access memory (MRAM) and other suchdevices. The ROM may comprise, for example, a programmable read-onlymemory (PROM), an erasable programmable read-only memory (EPROM), anelectrically erasable programmable read-only memory (EEPROM), or otherlike memory device.

Also, the processor 503 may represent multiple processors 503 and/ormultiple processor cores, and the memory 506 may represent multiplememories 506 that operate in parallel processing circuits, respectively.In such a case, the local interface 509 may be an appropriate networkthat facilitates communication between any two of the multipleprocessors 503, between any processor 503 and any of the memories 506,or between any two of the memories 506, etc. The local interface 509 maycomprise additional systems designed to coordinate this communication,including, for example, performing load balancing. The processor 503 maybe of electrical or of some other available construction.

Although the body shape description program 515 and other applicationprogram(s) 518 described herein may be embodied in software or codeexecuted by general purpose hardware as discussed above, as analternative the same may also be embodied in dedicated hardware or acombination of software/general purpose hardware and dedicated hardware.If embodied in dedicated hardware, each can be implemented as a circuitor state machine that employs any one of or a combination of a number oftechnologies. These technologies may include, but are not limited to,discrete logic circuits having logic gates for implementing variouslogic functions upon an application of one or more data signals,application specific integrated circuits (ASICs) having appropriatelogic gates, field-programmable gate arrays (FPGAs), or othercomponents, etc. Such technologies are generally well known by thoseskilled in the art and, consequently, are not described in detailherein.

Also, any logic or application described herein, including the traverseand tracking program 515 and the application program 518, that comprisessoftware or code can be embodied in any non-transitory computer-readablemedium for use by or in connection with an instruction execution systemsuch as, for example, a processor 503 in a computer system or othersystem. In this sense, the logic may comprise, for example, statementsincluding instructions and declarations that can be fetched from thecomputer-readable medium and executed by the instruction executionsystem. In the context of the present disclosure, a “computer-readablemedium” can be any medium that can contain, store, or maintain the logicor application described herein for use by or in connection with theinstruction execution system.

The computer-readable medium can comprise any one of many physical mediasuch as, for example, magnetic, optical, or semiconductor media. Morespecific examples of a suitable computer-readable medium would include,but are not limited to, magnetic tapes, magnetic floppy diskettes,magnetic hard drives, memory cards, solid-state drives, USB flashdrives, or optical discs. Also, the computer-readable medium may be arandom access memory (RAM) including, for example, static random accessmemory (SRAM) and dynamic random access memory (DRAM), or magneticrandom access memory (MRAM), In addition, the computer-readable mediummay be a read-only memory (ROM), a programmable read-only memory (PROM),an erasable programmable read-only memory (EPROM), an electricallyerasable programmable read-only memory (EEPROM), or other type of memorydevice.

Further, any logic or application described herein, including thetraverse and tracking program 515 and the other application program(s)518, may be implemented and structured in a variety of ways. Forexample, one or more applications described may be implemented asmodules or components of a single application. Further, one or moreapplications described herein may be executed in shared or separatecomputing devices or a combination thereof. For example, a plurality ofthe applications described herein may execute in the same computingdevice 500, or in multiple computing devices in the same computingenvironment 103. To this end, each computing device 500 may comprise,for example, at least one server computer or like device, which can beutilized in a cloud based environment. Additionally, it is understoodthat terms such as “application,” “service,” “system,” “engine,”“module,” and so on may be interchangeable and are not intended to belimiting.

FIG. 6 illustrates a point cloud of a leg obtained by the methodologyabove that suitably provides a shape description of a patient who has alymphedema grade of 1-2, where that shape description can suitably beused as set out elsewhere herein.

In a separate exemplary method of acquiring digital images from whichshape descriptions of a body part or body area of interest can beobtained and from which measurement information can optionally bederived, a provider acquires patient body part or body part area digitalimages using a hand-held technique, Such handheld technique is usefulfor a wide range of edema-related conditions, such as lymphedema atstages 1-3, with stage 3 being particularly relevant to the imagingbenefits resulting from this handheld methodology.

This handheld image acquisition methodology can be conducted as follows.(Note that a Structure Sensor configured with an iPad is used below, butthe technique can be used with any suitable imaging device and computingdevice that uses a software configuration.)

Arm Image Acquisition Technique (shown partially in FIG. 7 ):

-   -   a. The person's arm is positioned at approximately 90 degrees        from her body. Generally, the angle can be less than 90 degrees        if indicated by person mobility range, but for the best imaging        results the angle needs to be large enough to visualize        separation on the Structure Sensor/iPad combination between arm        and body, which is usually a minimum of 60 degrees, depending on        size of person's arm and body fat percentage.    -   b. The person's full arm is captured in the frame as shown on        the iPad screen including hand and fingers, with the frame also        being adjusted to include some of the person's body. The body        serves as a relevant reference point for segmenting the arm for        subsequent image processing.    -   c. The Structure Sensor/iPad combination is held by the operator        who moves the combination laterally along the length of the        person's arm while capturing views from the top, bottom, and        side planes. While capturing the images, the operator can view        the iPad screen to observe in real time the capture quality of        the image. Such observation ability is particularly useful at        the top and the bottom planes of the person's arm that have the        highest risk for poor scan quality, especially in persons with        complex morphologies. The operator will typically spend extra        time in these areas.    -   d. Folds or lobes on the person can require that the operator        rotate the Structure Sensor/iPad combination to capture the        “underside” of the folds.    -   e. Each arm can be captured one at a time in order to maximize        resolution of the scan.    -   f. Some persons can be instructed to hold onto a pole to keep        their arm still or in a stable position. This can be highly        useful for recent surgery or radiation persons because they        often lack arm strength and range of motion.

Leg Image Acquisition Technique:

-   -   a. Person is instructed to stand with legs wide enough to        achieve separation between legs in the scanning region.    -   b. For low-grade lymphedema, skinny legs, or scans focusing only        on the lower leg, the person stance is approximately hip-width        apart.    -   c. For higher grades of lymphedema, larger legs (especially        thighs), or when the edema is concentrated in the upper leg,        person stance may need to be wider.    -   d. Both leg images can be acquired substantially simultaneously.    -   e. The operator positions the segment of the legs in the        scanning window as appropriate—floor to above the knee for lower        leg scan and floor to above the gluteal fold for full leg scan.        The operator can acquire images as she walks 360 degrees around        the person while also at the same time moving the scanner up and        down.    -   f. The inner side of the person's legs has the highest risk of        poor scan quality. Because of this it is important that extra        effort is taken to get a clean scan of this area. This can be        done by aiming the sensor directly at the inner side of the leg        and ensuring that all surfaces can be visualized.    -   g. Folds can require that the sensor/tablet combination rotate        to capture the “underside” of the fold. This can be done by the        user positioning the combination at a position that it is below        the patent's skin fold and then aiming it up towards the person        so the underside of the fold is acquired in a plurality of        images.

Digital image acquisition by a provider's real time or substantiallyreal-time adjustment of received images of the person's body part orbody areas by movement of the imaging device in space during an imageacquisition process has been found by the inventors herein to beespecially useful when generating measurement information for personswith complex morphologies, such as persons with advanced edema and/orwho may be obese, in this regard, it has been determined that fixeddistance image acquisition setups (either with person rotating in placeor camera rotating around person—even if camera or person are moving upand down) often cannot acquire accurate reconstructions of body parts orbody part areas. Allowing the imaging device to freely move with sixdegrees of freedom, unconstrained by a mounting or support assembly,facilitates more detailed imaging of the person's body part or bodyareas by acquiring information at a variety of orientations anddistances about the person. The freedom of movement without constraintallows the imaging to be adjusted for complexities in the surfacemorphology of the person.

In notable aspects, when the image capture device is rotated around theperson's body part or body area, the device is not mounted to an arm orrod that rotates around a central point, such as a turntable. Stillfurther, the person is not rotated on a platform while image capture isunderway. In this way, the images are not captured along a predefinedreference frame. With the image capture device able to move with sixdegrees of freedom, imaging of the person's body part or body area canbe adapted (e.g., in real time or near real time) to ensure appropriateimaging or focusing on areas that are potentially problematic.

Using the inventive hand-held imaging methodology, the imaging devicecan be rotated or otherwise moved around the person's body part or bodypart area of interest during image capture, and the image can bereviewed by an operator who is acquiring the images in real time or theimage acquisition process can be reviewed remotely substantially in realtime by someone who is reviewing the image acquisition process in anoffsite location. With the latter, a person can be imaged in a locationremote to the medical provider, for example by herself or a familymember, to allow the person's condition to be monitored at a distance,or to allow the compression therapy prescription process and/or thecompression garment measurement processes to occur via telemedicinetechniques.

If, when moving the imaging device around the person, the operator candetermine that some portion of the person's body part or region ofinterest is not being well-imaged during the image acquisition step.Such lack of complete image acquisition of the body part or body area ofinterest may be returned on a screen to show “ridges,” “holes,” or“seams” in the body part or body area 3D reconstruction presented to theoperator substantially in real time. By reviewing the 3D reconstructionas it is being generated during image acquisition, the operator canspecifically image that area to generate an improved 3D scan for thatperson, where shape descriptions and, optionally, measurementinformation for the relevant body part or body area can be derivedtherefrom. This digital image acquisition and real-time review of theacquired images in relation to developing the shape description has beenfound to be especially useful for persons having deep tissue folds, suchas for persons with advanced edema/lymphedema and/or who are morbidlyobese.

In this regard, it has been found that prior art fixed plane digitalimage acquisition protocols (either with person rotating in place orcamera rotating around person—even if camera or person are moving up anddown) do not allow accurate reconstructions of tissue folds in persons.Therefore, shape descriptions and associated measurement information arenot attainable therefrom. Such folds are illustrated in FIG. 2 herewithwith a person presenting with an advanced stage of lymphedema, namelystage 3, in one of her legs.

With regard to the stages of lymphedema, the following informationapplies:

-   -   a. Stage 0 (latent): The lymphatic vessels have sustained some        damage that is not yet apparent, Transport capacity is        sufficient for the amount of lymph being removed. Lymphedema is        not present.    -   b. Stage 1 (spontaneously reversible): Tissue is still at the        pitting stage: when pressed by the fingertips, the affected area        indents and reverses with elevation. Usually upon waking in the        morning, the limb or affected area is normal or almost normal in        size.    -   c. Stage 2 (spontaneously irreversible): The tissue now has a        spongy consistency and is considered non-pitting: when pressed        by the fingertips, the affected area bounces back without        indentation. Fibrosis found in stage 2 lymphedema marks the        beginning of the hardening of the limbs and increasing size.    -   d. Stage 3 (lymphostatic elephantiasis): At this stage, the        swelling is irreversible and usually the limb(s) or affected        area is noticeably large. The tissue is hard (fibrotic) and        unresponsive; some patients consider undergoing reconstructive        surgery, called “debulking”. This remains controversial,        however, since the risks may outweigh the benefits and the        further damage done to the lymphatic system may in fact make the        lymphedema worse.

Still further, lymphedema can be assessed in relation to the severitywith which a clinician grades the patient's presentation:

-   -   a. Grade 1 (mild edema): Involves the distal parts such as a        forearm and hand or a lower leg and foot. The difference in        circumference is less than 4 cm and other tissue changes are not        yet present.    -   b. Grade 2 (moderate edema): Involves an entire limb or        corresponding quadrant of the trunk. Difference in circumference        is 4-6 cm. Tissue changes, such as pitting, are apparent. The        patient may experience erysipelas.    -   c. Grade 3a (severe edema): Lymphedema is present in one limb        and its associated trunk quadrant. Circumferential difference is        greater than 6 centimeters, Significant skin alterations, such        as cornification or keratosis, cysts and/or fistulae, are        present. Additionally, the patient may experience repeated        attacks of erysipelas.    -   d. Grade 3b (massive edema): The same symptoms as grade 3a,        except that two or more extremities are affected,    -   e. Grade 4 (gigantic edema): In this stage of lymphedema, the        affected extremities are huge, due to almost complete blockage        of the lymph channels.

The inventors herein have determined that all stages and grades can beassessed with the handheld image acquisition technology herein, whereasthe fixed platform methodology provides clinically accurate results forlymphedema stages 0-2 and grades of 1-2.

While shape description information can be used in the selectionprocess, it has been determined herein that the methodology can alsogenerate one or more body part circumference measurements, in additionto shape descriptions as discussed elsewhere herein. The inventorsherein have determined that such improved body part circumferenceinformation can, in turn, allow improvements in the selection ofpre-fabricated compression garments by a user. In this regard, whenobtaining accurate 3D geometry and associated shape information for abody part, any body part circumference derivable therefrom would beconform to the actual—that is, real-life—circumference for the personincluding all complexity of the surface morphology.

Furthermore, the inventive methodology allows one or more body partcircumferences to be oriented relative to a body region of interest toensure accurate measurement thereof which, in turn, results in improvedselection of pre-fabricated compression garments. For example, a bodypart circumference can be generated at a defined body location, such asthe narrowest part of a wrist, with that location defined can be used asa reference point for the remainder of the body part on which thedefined body part location is situated. Accordingly, one aspect of theinventive methodology herein comprises defining a location on at leastone area on a body part as a reference point for fitting of apre-fabricated compression garment.

In contrast to prior art measurement techniques, accurate generation ofat least one body part circumference, with or without generation and/oruse of shape description information, the present invention enhances theability to find the best fit pre-fabricated garment(s) for the specificpatient's body part. In this regard, and taking the wrist as an example,generation of an accurate body part circumference at a defined location,such as the narrowest location, can better ensure that the correctlysized compression garment is selected. If the criteria for selection ofa compression garment for a person is to identify the smallest area onthe body part being fitted—that is, the smallest circumference—providingof a larger circumference may result in an incorrect selection of acompression garment from the collection of compression garments. Forexample, if the narrowest circumference of a wrist is 8 inches, but thegenerated measurement is 8.5 inches, a compression garment fitting 8.5inches would be the indicated selection. A compression garment selectedfor this larger wrist circumference will be larger than the patient'sactual wrist circumference thus resulting in a compression garmentselection that is not well-fitted to the person.

Such incorrect body part circumference measurement can result with thetape measure method when the clinician's measurement is slightly offfrom the intended location, which can happen with even highly trainedpersonnel due to the highly qualitative nature of taking measurements byhand. For prior art scanning techniques, such as the Isobar Compressionmethodology discussed herein, down sampling of the scanner data canresult in removal of the data associated with the relevant body partmeasurement in the analysis because such methods are not sensitive toidentification of shape aspects of the body part. This could result inthe incorrect measurement being provided for selection of thecompression document.

Yet further, the true—or actual—geometric information for the wearer'sbody part being fitted for a pre-fabricated compression garment canautomatically be determined for a wearer. For example, a wearer'sminimum wrist circumference and/or maximum forearm circumference can beautomatically derived from images of the wearer's arm. This can betterensure that a generated identification of a pre-fabricated compressiongarment for the wearer is, in fact, an accurate selection for thatwearer. To this end, if a wearer has a complex body morphology, such asa lobe, fold, or well-developed muscle architecture in a location awayfrom the location where a standard measurement for a pre-fabricatedcompression garment as shown, for example, in FIGS. 8 and 9 , thestandard measurement technique may not identify a garment that will beeffective for that wearer. Such a garment may be ill-fitting, such asbeing too tight, thus reducing the likelihood that the wearer willconsistently wear the garment, as well as likely reducing theeffectiveness of the garment due to incorrect pressure application.

Moreover, using standard compression garment fitting methodology,observation of a complex surface morphology may result in arecommendation that the wearer be fitted for an expensive andtime-delayed custom compression garment. The inventive methodology canbe used to automatically identify a plurality of circumferences along alength of a wearer's body part being fitted with a pre-fabricatedcompression garment so as to allow identification of a mis-match betweenan expected wearer body part circumference along a length of the bodypart and a corresponding circumference on a pre-fabricated compressiongarment. For example, if a person being fitted for a compression garmentin the form of an arm sleeve has wrist, forearm, elbow and arm pitmeasurements that indicate that a particular pre-fabricated compressiongarment is the correct size, but the wearer has an abnormally prominentbicep area, the inventive methodology can incorporate such informationin an identification (or not) of a pre-fabricated compression garmentappropriately fitted for that wearer. Information can be provided tothat wearer directing the selection of an appropriately fittedpre-fabricated garment from a plurality (or collection) of garments.

As discussed previously, body part information obtained according to thepresent invention can also be used to fit pre-fabricated compressiongarments for a wearer to provide an improved fitting methodology. Theinventive methodology allows accurate measurement information to beobtained for one or more body parts or body areas of interest (e.g.,arm, leg, trunk, neck, etc.). The measurement methodology of the presentinvention provides substantially accurate anthropometric measurements,as well as high resolution information for the relevant body part orbody part areas so as to enable excellent reproductions of the person'sphysique, especially in relation to a person's specific musclearchitecture. Furthermore, the invention enables body part measurementsto be obtained without the typical inter-operator error, thereby betterstandardizing the resultant fit and subsequent performance of thecompression garments.

In a significant aspect, the inventive methodology herein providesimprovements in the selection of pre-fabricated compression garments fora person in need of compression treatment on at least one body part. Inthe specific context of pre-fabricated garments, the inventivemethodology enables more accurate and more consistent set of derivedmeasurements to inform sizing of pre-fabricated compression garments andselection thereof, which would subsequently ensure a better fit and abetter performing garment. Off the shelf compression garments—that is,those not based on custom patient body specifications—must necessarilyeach be sized to fit a reasonable number of people for each SKU, atleast because retailers require that the number of SKUs be rationalizedfor each supplier. People's body parts are far from standardized,however. A 6 foot, 200 pound man who is a body builder will likely havea very different arm muscle architecture than a male swimmer of the sameheight and weight. In this example, it can be seen that the current useof generalized compression garment sizing that is directed towardreduction of SKU number in a retail environment can allow each of theseathletes to obtain compression garments that are suitably sized toprovide effective post-exercise compression treatment.

To this end, pre-fabricated medical compression garments aremanufactured and available in a range of standard sizes, which areselected for a patient based on their limb circumference and limb lengthmeasurements. Each measurement has a range that corresponds to a certainsize. Each major brand has a specific fitting guide for each type ofcompression garment they provide, and the selection of garments bothwithin and among manufacturers can be a complex and confusing endeavor.The specific manufacturer guides explain which circumferencemeasurements are required for selecting the best fit ready to weargarment that they supply. Measurements usually contain anatomicallandmarks such as the smallest circumference at the ankle and thelargest circumference at the calf. The clinician or trained fitter willphysically inspect the patient during a visit and obtain the appropriatemeasurements according to the size guide. Garments can be selected forarms, hands, legs and feet, for example.

Pre-fabricated garments are each usually available in differentcompression ranges. To ensure proper fitting, these garments typicallyrequire a clinician or a “certified fitter” trained in measuring limbsfor fitting garments to measure a person's limb circumference atdifferent locations along the length thereof according to a fittingguide for each specific garment brand and style. The pre-fabricatedgarment is then selected based on a “best fit” match between thegenerated measurements and the available pre-fabricated garments.

The inventive methodology can be used to obtain the requiredmeasurements needed to select the best size of pre-fabricated garmentfrom a collection of compression garments. Such is a significantimprovement over the prior art. The generated measurement information,which includes at least limb measurement information, is compared toprovided measurements associated with the collection of pre-fabricatedcompression garments. A best-fit match between the generated user bodypart measurements and the measurements of each of the collection ofpre-fabricated compression garments is provided, whereby at least onepre-fabricated compression garment is identified for selection by theuser from the collection.

Yet further, the inventive methodology also allows automation andstandardization of a wearers anatomic landmarks and associatedcircumferences and, in some aspects, length measurements—that is,information pertinent to compression garment sizing—in the region ofsuch identified landmarks and areas proximate thereto. Once a wearer'smeasurements are obtained in a first wearer data collection step, theinformation can be stored for later use. These stored user measurementscan be recalled at a later time for use in a subsequent compressiongarment fitting operation. Such stored information can also be recalledat a later time to assess whether the wearer's body part circumferenceshave changed between measurement events. This can facilitatedetermination of whether the wearer has experienced improvement or lackthereof in actual or potential edema-related conditions, for example.

In some aspects, the invention comprises selecting a pre-fabricatedcompression garment from a plurality (or collection) of pre-fabricatedcompression garments. The plurality (or collection) can be from a singlemanufacturer or a plurality of manufacturers. When from a singlemanufacturer, the best fit from a single source can be identified for auser. When from a plurality of manufacturers, the user can be providedwith the best fit from a variety of manufacturers.

The information derived from a collection of wearer measurementsobtained from the inventive methodology can be incorporated into adatabase of information. Analysis of such database can be used togenerate a library of measurements that can be deployed to generatepatterns for pre-fabricated compression garments, as well as compressiongarments generated therefrom.

In providing the identification to a user for selection, digital imagesof a selected body part are acquired as set out elsewhere herein. Whilea variety of pre-fabricated compression garments can be fitted for awearer in accordance with the present invention, compression garmentsconfigured for use on an arm or a leg are particularly well suited forthe present invention. For example, pre-fabricated compression garmentssimilar to those pictured for the arm and leg in FIG. 3 herewith can besuitably fitted.

In order to fit the pre-fabricated compression garments to a wearer, afirst wearer outer circumference measurement is generated from thedigital images. The methodology can automatically determine the relevantbody part area for use in determining the wearer circumferences to beused in identification of an appropriate pre-fabricated compressiongarment for that wearer. As shown in FIG. 8 , for arm compressiongarments, the circumference of wearer arm 800 can be generated at fitlocations that are the wearer's wrist area 805, forearm area 810, elbowarea 815, upper arm area 820 and axilla area 825. The number andlocation of the circumference measurements can be dependent on whetherthe arm sleeve is for the lower arm only (i.e., length 830) or it is forthe whole arm (i.e., lengths 830 and 835). To generate the circumferenceof the wearer's wrist 805 for an arm sleeve, for example, thecircumference of the narrowest part of the wrist can be generated viaimage processing as discussed herein. As shown in FIG. 9 , for acompression stocking for leg 900, the circumference of ankle area 905can be generated via image processing, as well as the widest calfcircumference 910 and knee circumference 915. Further as shown in FIG. 9, if a compression pantyhose is the garment to be fitted, circumferencemeasurements at the widest portion of thigh 920 and at hip 925 can betaken in addition the lower leg measurements. As noted previously, thelocations where such circumference measurements are obtained can begenerated automatically via processing of the images according to theinventive methodology.

In order to identify the best fit for a wearer, dimensions for theplurality of pre-fabricated compression garments are obtained, where aplurality of circumference measurements for each of the garments isderivable therefrom. The plurality of circumference measurements aretaken along a length of the compression garment. For example, for a fullarm compression garment, measurements can be taken at least the wristarea, the forearm area, the elbow area and the armpit area, where suchareas are in relation to where the compression garment will fit on thewearer. More circumferences can be generated along the length of thecompression garment.

Generally, a compression garment for treatment of edema-like conditionswill be very thin, for example, about 1 or 2 mm, such that the innercircumference and the outer circumference of a pre-fabricatedcompression garment will be essentially the same. Such circumferencemeasurements can be generated from, for example, specifications used tofabricate the compression garments via computerized knitting operations,as discussed hereinafter. If the pre-fabricated compression garmentcomprises a fabric or other type of outer cover, such as might be thecase with a compression garment that is intended for exercise or thelike, the thickness may be such that the inner circumference and outercircumference of the compression garment will not be essentially thesame. In this case, the inner circumference of the garment will serve asthe measurement circumference reference point. Yet, further, the innercircumference is the baseline of measurement for the compression garmentto eliminate any differential between the inner and outer circumferencemeasurements for the pre-fabricated compression garments. Still further,such garment circumference measurements can be obtained from physicalmeasurement of the inner and/or outer circumferences of a plurality ofpre-fabricated compression garments and incorporation of the resultsinto software instructions associated with the inventive methodology.This latter measurement method is particularly useful when theidentification of a pre-fabricated compression garment from is from aplurality of compression garments for which computerized information isnot directly obtainable, such as for compression garments that are madeby different manufacturers.

At least a first circumference measurement at a first wearer fitlocation is derivable from the provided compression garment dimensions.In some aspects, a second circumference measurement at a second wearerfit location is derivable from the compression garment dimensions. Stillfurther, three, or four, or more circumference measurements at three, orfour, or more second fit locations are derivable from the compressiongarment dimensions. At least two or more wearer fit locations andgarment fit locations can be generated for each selected body part.Indeed, a large number of circumferences can be generated along thelength of the body part, and these circumferences can be associated withthe same number or fewer of circumferences on a pre-fabricatedcompression garment.

To identify the best fitting pre-fabricated compression garment for awearer from a plurality (or collection) of pre-fabricated compressiongarments, each of the derived circumference measurements at the firstgarment fit location for each of the plurality of pre-fabricatedcompression garments is compared to the first wearer fit locationcircumference. The wearer fit location circumference that is closest tothe compression garment circumference is identified as the best fit andinformation is provided to the user, Such identification can be providedto allow selection thereof for use.

To obtain a good match between the wearer body part and thepre-fabricated compression garment so as to ensure effective compressiontherapy, the wearer fit location and the garment fit location are thesame, in substantial aspects. For example, the wearer fit location canbe at or near the narrowest part of a wearers wrist, and the garment fitlocation is at or near the same wrist location as configured in thecompression garment. Or the wearer fit location can be at or near thewearer's elbow, and the garment fit location is at or near the elbowlocation configured into the compression garment. Still further, thewearer fit location can be at or near the wearer's ankle, and thegarment fit location is at or near the ankle location configured intothe compression garment. Or the wearer fit location can be at or nearthe wearers knee, and the garment fit location is at or near the kneelocation configured into the compression garment. Any other location onthe wearer's arm or leg can be the provided circumference as the wearerfit location, with the garment fit location associated therewith alsobeing the same.

Referring to FIG. 10 , a process 1000 for fitting a pre-fabricatedcompression garment for a wearer according to the present disclosure isillustrated. In a first step 1005, a body part of or body area of apatient or wearer is selected or designated for imaging to fit acompression garment. In step 1010, digital imaging of the selected bodypart or body area is performed, thereby acquiring digital images of thebody part. Such acquired images can be processed in 1015 to generate ashape description information for the selected body part or body area,from which wearer body part circumferences are derivable. One or morewearer fit location outer circumference measurements can be generatedfor the body part. A length for the wearer body part can also bedetermined. In step 1020, dimension information for one or morecompression garments (e.g., pre-fabricated compression garments) can beprovided. The dimension information can include, but is not limited to,circumference measurements for the garment fit locations and/or thegarment length measurement. In 1025, the garment measurements of thecompression garments can be compared with the wearer fit locationcircumference measurement and/or the length of the wearer body part andused to identify at least one compression garment at 1030. Theidentified compression garment or garments can be those having a garmentfit circumference measurement that is closes to the corresponding wearerfit location circumference measurement. In addition, the garment canhave a length measurement that is closest to the wearer body partlength. The identified compression garment can be supplied to the wearerat 1040.

In some aspects, the wearer imaging can be conducted in a firstlocation, and orientation of the imaging device relative to the wearercan be operated wholly or in part from a second location, that is,remotely. Such a configuration can allow identification of anappropriately sized pre-fabricated compression garment without thewearer having to travel to another location or for a person to travel tothe location of the wearer to acquire the images. When the wearer is ata remote location from the operation of the image acquisition process,instructions can be provided to the wearer of how to place her body partto allow images suitable to generate the at least one wearer outer bodypart circumference to be generated, Such instructions can be verbal orprovided on a screen visible to the wearer during the image acquisitionprocess.

Processing of the image acquisition steps is generally conductedautomatically by the computer such as, e.g., the computing device 500 ofFIG. 5 . Instructions provided to the wearer on how she should positionher body part can also be generated automatically by the computer as aresult of image processing that indicates that the images acquired donot yet allow a suitable wearer location fit circumference to begenerated. Alternatively, remote instructions during the imageacquisition process can be from a human operator who is observing theimage acquisition process remotely in real time. Still further,instructions provided to the wearer during the image acquisition processare provided in by both automatically by a computer and by a humanoperator observing the image acquisition process remotely.

As noted, wearer body fit location circumferences can be associated withone of a plurality (or collection) of pre-fabricated compressiongarments. Typically, pre-fabricated compression garments are sizedaccording to relevant fit circumferences, such as ankle and calf forcalf height compression stockings. One such calf height sock is aTraverse™ knee high sock. (Sigvaris, St. Gallen, CH). Body location fitcircumferences in the pre-fabricated compression garments according to amanufacturer-specific sizing implementation. As an illustrative example,for the ankle circumference the Traverse knee high socks use “small” (7to 8.5 inches), “medium” (8.5 to 10 inches), “large” (10 to 11.5inches), and “extra large” (11.5 to 14 inches). For the calfcircumference the Traverse knee high socks use “small” (11 to 15.5inches), “medium” (12.5 to 17.5 inches), “large” (14 to 20 inches), and“extra large” (16 to 24 inches). Plus sizes are also available. Forcompression pantyhose, additional circumferences for the widest portionof the wearer's thigh and hip will be obtained. For pre-fabricated armcompression garments, measurements will be taken at the wrist and belowthe elbow for gauntlet-type garments, and above the elbow for fullsleeved garments. Again, each manufacturer will have its own set ofsizing parameters, and such sizing parameters will be included in thedimension information used in the inventive methodology.

As for a leg compression garment, the circumferences of various leglocations are typically generated and the manufacturer's fit chart isreviewed to match the fit to the wearer arm measurements. For fitting ofJuzo® arm sleeve (Cuyahoga Falls, Ohio), six different size options areprovided, plus additional options for larger cupper arm and elbowcircumferences. Two different length options, “regular” with a wrist toarmpit length of <43 centimeters and a long for a wrist to armpit lengthof >43 centimeters are provided.

In order to select an appropriately fitted pre-fabricated knee highcompression stocking using prior art methods, the user will also have tomeasure each of her ankle at the correct location, and her calf at thewidest location, and then use a selection chart, that will also includelength measurements. The body part circumferences generated from theinventive image acquisition and processing methodology herein allows auser to obtain information about what size pre-fabricated compressiongarment should be selected without having to go through complicatedphysical measurement steps and product identification steps.

As provided by the fit instructions for the compression knee highs shownabove, two or more locations for the wearer body part circumference canbe generated, as well as a length. For the compression pantyhose, fourlocations for the wearer body part circumference are generated, as wella length to the wear's gluteal fold. For an arm sleeve compressiongarment, five wearer body part outer circumferences can be generated,namely under the axilla or armpit region, the middle of the upper arm,the elbow, the middle of the forearm, and the wrist. For a partialsleeve arm compression garment, two wearer body part outercircumferences can be generated, namely the wrist and the elbow. For aglove, two body part outer circumferences, namely the base of the fourfingers under the thumb and the wrist can be generated. Lengths for thefingers, forearm, and upper arm to the armpit can also optionally begenerated to ensure a better fit lengthwise. As noted, the inventivemethodology allows such circumferences to be automatically generated, aswell as their location on a specific wearers body part. The length ofthe specific wearer's body part can be automatically generated, also.

In addition to body part circumferences, the image acquisition andprocessing steps can provide relevant lengths of the body parts beingfitted with the pre-fabricated compression garments. Such lengthmeasurements are shown, for example, as 830 and 835 in FIG. 8, and 930and 935 in FIG. 9 . Again, the enhanced information generatable from theinventive processes herein provide more accurate fitting than availablewith prior art imaging methods, at least because down sampling of theseimages during the processing steps. Such length measurements will ensurean adequate fit along the entire body part. For example, for leg heightcompression socks, the calf length can be associated with a “petite”garment (≤14 inches), a “short” garment (≤16 inches), a “medium” garment(≤16 inches).

While the length of the relevant body part can be automaticallygenerated from the image generation and processing methodology of thepresent invention, to the extent that body part length is relevant tothe identification of pre-fabricated compression garments, such lengthcan be obtained by other techniques. For example, a wear's height can beincorporated as a selection or input parameter in the softwareinstructions where the wearer or an operator can be asked to providesuch height. Or a wearer can select or input a pants leg size. Or aruler or measurement can be used, such as a laser measuring device, andbody part length information so generated can be used in thepre-fabricated garment selection process.

Manufacturers of pre-fabricated compression garments generally include avariety of selectable parameters in a collection of garments within aproduct line. Accordingly, in some aspects, the present invention willalso incorporate selection of one or more of the compression level(e.g., 10 to 20 mm Hg, 20 to 30 mm Hg, 30 to 40 mm Hg, 40 to 50 mm Hg,or 50 to 60 mm Hg, or any range of endpoints), fabric/material (nylon,wool, rubber), color (by skin tone level, white, or black), open orclosed toe for leg, gloved or ungloved for arm, shoe size, and wearergender. Such information can be incorporated as selection or inputcriteria presented to the wearer or operator to further simplify thefitting process for a wearer. Further, information about wearer identityand preferences can be maintained in the system for subsequent selectionprocesses.

In notable aspects, the methodology herein allows the generation ofhighly accurate geometric information for a patient's body part or bodyarea of interest by generating one or more shape descriptions for thatbody part or body area. Generation of shape descriptions for the bodypart or body area of interest in a specific patient providesignificantly enhanced measurement information as compared to thetraditional circumference and length measurements used to generatecompression garments. Accordingly, the inventive methodology can be usedto generate accurate, geometrically-based, 3D representations for aspecific patient body part or body area of interest.

Notably, the methodology of the present invention allows substantiallyaccurate shape description information, which also includes body partcircumference information derivable therefrom, to be generated invirtually any location at which the patient might be located using theimage generation and processing methodologies disclosed elsewhereherein. The relative simplicity of generating the digital images from aspecific patient means that it is possible for patients to take theftown images in convenient locations. The increased simplicity provides apreviously unrealized ability to enable regular monitoring of patientbody part or body area measurements, for example, a home setting or inother extra-clinical settings, thereby greatly enhancing the ability togenerate and maintain properly fitted compression garments, be they fortherapeutic treatment or otherwise. Because the person can be measured,and therefore fitted, in their home or other private location, access towell-fitting compression garments for various uses can be greatlyenhanced.

Yet further, one or more or of a plurality of body contour measurementsderived from one or more shape descriptions of a body part or body areaof interest can be combined to form a compression garment configured forwearing by a user. For example, the compression garment of the inventionmay comprise shorts, long tights or tops, either as a single garment orin a combination of garments intended to be worn as a suit. As anexample, an athlete may have arms or legs of different exterior contoursdue to dominance, injury or other factors. The improved measurementcapabilities disclosed herein can enable custom bicycle pants to begenerated for a cyclist with the legs precisely fit to the volume ofthat person when the measurement information is provided to generate apattern or other information suitable to manufacture such a garment. Thepresent invention can also be utilized to generate custom-fittedswimsuits or other athletic apparel where compression comprises at leasta part of the functional aspect incorporated into such garment. Usingthe body part circumference information obtainable from the presentinvention, the selection of pre-fabricated athletic clothing can beenhanced. For example, a pre-fabricated swim garment havingcircumference information associated therewith can be identified asbeing the best fit for a specific wearer.

The material of which the compression garment of the invention is mademay be chosen from a wide variety of fabric or different fabrics. Insome aspects, the garment of the invention can be made of panels offabrics of elastane or similar stretch material, often combined withnylon or polyester or similar stretch materials of 40, 60 or up to 120denier material. The fabric can comprise selected stretch and recoverycharacteristics. The stretch along the warp of the fabric can be fromabout 120% to about 225% and its number for recovery is from about 10%to about 25%. The material can incorporate a “wicking” effect, so thatin use it draws moisture from the body. Such materials are known.

As would be recognized, modern knitting machines are highly integratedwith processing controls and software. In this regard, the highlyaccurate measurement information generated from the disclosed herein canbe incorporated in the compression garment fabrication instructionsassociated with use of the knitting machine. Such fabricationinstructions can be transmitted by the imaging devices and associatedequipment via the cloud. Alternatively, the measurements can be providedto the knitting machine by uploading the measurements on a USB device orthe like, as would be known.

Compression garments generated from fabrication information generated bythe inventive methods herein can be made from thicker (but breathable)materials and knitted row by row as a flat piece, which are shaped andproduced by adding or removing needles during the production process,according to the exact measurements of the person. The finished flatpiece can then be joined by a seam to form the garment. Such heavierknit materials can provide greater stiffness resulting in greaterresistance and better containment of the swelling than ready-madegarments (so-called stiffness factor). As such, such thicker materialsare more suitable for applications where a higher compression value isrequired, such as for lymphedema treatment.

Still further, compression garments generated from the inventivefabrication information can be prepared in one piece, such as from acontinuous knitting machine.

Yet further, the inventive measurement methods can be utilized toprovide compression garments with lower compression values, which mightbe more suitable for sport-type applications. In this regard, relativelythin and sheer fabrics that are continually knitted in a circularfashion on a cylinder and thus have no seam. As would be recognized,varying stitch height and yarn tension create the appropriate shape andsize based on the measurements provided in the manufacture thereof.

The present invention can also comprise patterns for use in preparingcompression garments. Such patterns and any associated compressiongarments will be specifically associated with the body features of theperson being fitted for, and therefore treated with, the compressiongarment. Still further, the methodology herein can be used to select apre-fabricated compression garment of a predetermined size, that is, an“off the shelf” or “ready to wear” garment.

Various designs or constructions can be included in the compressiongarment to provide improved functionality relating to compressionactivity. For example, US Patent Application Publication No.20140200494, the disclosure of which is incorporated herein in itsentirety by this reference provides a purported improved functionalitybased upon the knitted pattern in the resulting garment. Yet further,U.S. Pat. No. 9,345,271, the disclosure of which is incorporated hereinin its entirety by this reference, illustrates how variable pressure canbe generated along the length of a compression garment via stitchingtechniques. Yet further, compression garments of the present inventioncan comprise a plurality of panels having variable compression fabricwithin or added over panels of other compression fabric to generateimproved muscle support. Still further, the methodology of the presentinvention allows measurements to be generated to provide compressiongarments where compression can be placed in particular on some joints ormuscles. This, in turn, allows incremental compression to be achieved inthe garment. Such incremental compression has been found to increasestrength and stability on the joints, whilst supporting the muscles.This is a variation on the existing art where the support can be invokedby the wearer, choosing between an active state and a passive state.Such varied compression features can be identified for incorporation asa result of the improved limb or body part shape possible by themeasurement techniques of the present invention.

In addition to the measurement information generated from the person,features relevant to the garment construction can also be incorporatedinto the information used to create the compression garment specificallyconfigured to fit the person. In this regard, the information used tofabricate each compression garment can further include a desiredcompression, a desired compression class, whether the compression needis for prophylaxis, a degree of edema or vascular insufficiency of theperson, or an indication of compression sensitivity of the person, suchas if the person has a skin condition where compression might causedamage to the person, Where the additional information is a positiveindication of compression sensitivity of the person, the expectedcompression of the given garment can be a lowest expected compression ofa set of garments with acceptable expected compression, and the givengarment can be determined to meet the compression need of the person inresponse to the positive indication of compression sensitivity.

In further aspects, the compression garments generated according to themethodology herein can be configured with a plurality of sensors. Thesensors can be utilized to measure and/or diagnose muscle behavior in aperson, such as by assisting in the evaluation of an athlete'sperformance, as disclosed in US Patent Application Publication No.20140259267, the disclosure of which is incorporated herein in itsentirety by this reference. Yet further the one or plurality of sensorscan incorporate functionality that provides therapeutic benefits to auser. In such latter example, the selective constriction and dilationdisclosed in US Patent Application Publication No. 20160120734 isillustrative, of which the disclosure therein is incorporated herein inits entirety.

In one or more aspects, the sensors can be positioned in one or aplurality of locations on a compression garment generated for use on aperson's leg. For example, the one or a plurality of sensors can bepositioned proximal to the person's vastus lateralis, vastus medialis;vastus intermedius, rectus femoris, biceps femoris, semimembranosus,semitendinosus, gastrocnemius, soleus, or plantaris. Yet further, theone or plurality of sensors incorporated in or associated with thecompression garment can be positioned in one or a plurality of positionson a generated for use on a person's arm. In this regard, the one orplurality of sensors incorporated in or associated with the compressiongarment can be positioned proximal to the persons' biceps, triceps,brachioradialis, extensor carpi, radialis longus, or deltoid. Asdescribed elsewhere herein, the improved measurements possible with theinventive methodology herein provide improved fit for the compressiongarments. Similarly, placement of the sensors in the compressiongarments will be improved because the anthropometric measurementtechniques of the present invention can generate better identificationof the relevant locations of a person's arms or legs.

While the present invention is primarily directed toward improvedfitting of compression garments, and garments made therefrom, thepresent invention can also be used to generate anthropometricmeasurements for use to create custom clothing. The variety of garmentsthat can be generated from the inventive anthropometric measurementtechniques are expansive, and are limited only by the desire of personsto have access to custom-fit garments. In non-limiting examples, theinventive measurement techniques herein can be used to generate dresses,suits, trousers, jackets, shapewear, jeans, and the like. Theanthropometric measurements can be provided to a pattern engineer togenerate custom clothing, that is clothing that is created from apattern generated from the measurements of a person for whom the garmentis intended to be worn. With the proliferation of computerized sewingmethods, such as those available in the near future from SoftWearAutomation (Atlanta, Ga.), the anthropometric measurement methods of thepresent invention will increase the accessibility of custom clothing tothe public. Methodologies for generating custom-fit clothing from aperson's measurements are disclosed, for example, in US PatentApplication Publication No. 20140277663, the disclosure of which isincorporated herein in its entirety by this reference.

Yet further, the measurement methodology of the present invention can beused to improve selection of ready to wear clothing for a person. Inthis regard, the anthropometric measurements obtained can be input intoa look up table, for example, to provide improved fit selection for aperson. As an example, a person can obtain measurements that can bematched with the dimensions (or fit characteristics) of various clothingtypes to reduce uncertainty in determining whether a particular type ofclothing will fit the person. Such improved fit probabilities canfacilitate purchases of clothing online, for example. One example ofimproved fit methodologies that can be utilized with the anthropometricmeasurement methodology of the present invention is illustrated in U.S.Pat. No. 7,398,133, the disclosure of which is incorporated herein inits entirety by this reference.

A number of embodiments have been described but a person of skillunderstands that still other embodiments are encompassed by thisdisclosure. It will be appreciated by those skilled in the art thatchanges could be made to the embodiments described above withoutdeparting from the broad inventive concepts thereof. It is understood,therefore, that this disclosure and the inventive concepts are notlimited to the particular embodiments disclosed, but are intended tocover modifications within the spirit and scope of the inventiveconcepts including as defined in the appended claims. Accordingly, theforegoing description of various embodiments does not necessarily implyexclusion. For example, “some” embodiments or “other” embodiments mayinclude all or part of “some”, “other,” “further,” and “certain”embodiments within the scope of this invention.

What is claimed is:
 1. A method for providing compression garmentsconfigured for a body part or body area of a patient in need ofcompression therapy comprising: a) acquiring a first set of digitalimages of a selected body part or body area of interest for a patient inneed of compression therapy, the first set of digital images includingsurface morphology of the selected body part or body area; b) processingthe first set of digital images by a computing device to generate afirst three-dimensional image information for the selected body part orbody area, wherein the first three-dimensional image informationincludes surface morphology; c) providing a first compression garmentfabricated, designed, or selected from the first three-dimensional imageinformation, wherein the first compression garment comprises bothselected body part or body area dimensions and compression valuesconfigured to be therapeutically appropriate to provide a firstprescribed or indicated amount of compression therapy to the patientwhen the patient wears the first compression garment on the selectedbody part or body area; d) acquiring a second set of digital images ofthe selected body part or body area after the patient has worn the firstcompression garment for a first period of time on the selected body partor body area and processing the second set of digital images by thecomputing device to generate second three-dimensional image informationfor the selected body part or body area, wherein the secondthree-dimensional image information includes surface morphology; and e)providing a second compression garment fabricated, designed, or selectedusing the second three-dimensional image information, wherein the secondcompression garment comprises selected body part or body area dimensionsand compression values configured to be therapeutically appropriate toprovide a second prescribed or indicated amount of compression therapyto the patient when the patient wears the second compression garment onthe selected body part or body area, wherein the method is configured toover a period of time either or both i. monitor a regression orprogression of a clinical diagnosis in the patient over the period oftime; and/or ii. provide a plurality of compression garments configuredfor providing one or more prescribed or indicated compression therapyregimes to the patient.
 2. The method of claim 1, further comprising: a)acquiring an additional set of digital images of the selected body partor body area of the patient after the patient has worn the secondcompression garment for an additional period of time and processing theadditional set of digital images by the computing device to generateadditional three-dimensional image information for the selected bodypart or body area, wherein the additional three-dimensional imageinformation includes surface morphology; b) identifying surfacemorphology changes between the second three-dimensional imageinformation and the additional three-dimensional image information; andc) providing an additional compression garment comprising dimensions andcompression values configured to be therapeutically appropriate toprovide an additional prescribed or indicated amount of compressiontherapy to the patient when the patient wears the additional compressiongarment on the selected body part or body area.
 3. The method of claim1, further comprising receiving a patient clinical diagnosis comprisingone or more of: edema, lymphedema, venous eczema, ulceration, deep veinthrombosis, or post-thrombotic syndrome.
 4. The method of claim 1,wherein the monitoring of the regression or progression of the clinicaldiagnosis is by a user from a computer, smartphone or other computerdevice.
 5. The method of claim 1, wherein the processing of the digitalimages by the computing device is associated with a patient diagnosiscomprising edema, lymphedema, venous eczema, ulceration, deep veinthrombosis, or post-thrombotic syndrome.
 6. The method of claim 1,wherein the processing the digital images by the computing deviceincludes generating circumference measurements, length measurements andshape description measurements of the selected body part or body area ofthe patient.
 7. The method of claim 1, wherein the selected body part orbody area comprises for the patient: (i) a lower body part or (ii) anupper body part and the first period of time is greater than 1 week. 8.The method of claim 1, wherein the selected body part or body areacomprises: a) all or part of an arm; b) all or part of a leg; c) a chestarea; d) a neck area; e) a hand; or f) a foot.
 9. The method of claim 1,wherein the first and second sets of digital images of the selected bodypart or body area are acquired by a user or a device moving an imagingdevice around the selected patient body part or body area, and whereinthe operation of the imaging device is optionally controlled remotely.10. The method of claim 9, wherein an image acquisition report ispresented on a screen that is in operational engagement with the imagingdevice and wherein a digital image acquisition report is monitorable bythe user or by the device substantially in real time during the digitalimage acquisition, wherein the image acquisition report includesinformation received about a three-dimensional reconstruction of theselected body part or body area, and wherein the user or the device canadjust the digital image acquisition in response to the receivedinformation.
 11. The method of claim 1, wherein the processing comprisesgenerating shape description information for the selected body part orbody area, wherein the generated shape description information comprisesgeometric information for the selected body part or body area, thegeometric information being associated with the surface morphology ofthe selected body part or body area of the patient.
 12. The method ofclaim 11, wherein said processing further comprises deriving measurementinformation for the selected body part or body area from the shapedescription information.
 13. The method of claim 1, wherein theprocessing of the first set of digital images by the computing devicecomprises generating shape description information for the selected bodypart or body area, wherein the generated shape description informationcomprises geometric information for the selected body part or body area,and wherein the processing generates two or more sets ofthree-dimensional image information for the selected body part or bodyarea and generates a therapeutic diagnosis comparing the two or moresets of three-dimensional digital image information.
 14. An apparatusadapted to perform the methods of claim 1, the apparatus comprising: a)a sensor module adapted to acquire the first and second sets of digitalimages of the selected body part or body area, the first and second setsof digital images including the surface morphology of the selected bodypart or body area; and b) a data processor adapted to receive signalsoutput from the sensor module and to generate the first and secondthree-dimensional image information for the selected body part or bodyarea including the surface morphology, wherein the signals representdetected digital images.
 15. A method for providing a therapeuticcompression garment for a patient comprising: a) acquiring digitalimages of a selected body part or body area of interest in the patientin need of compression therapy, the selected body part or body areahaving a surface morphology; b) processing the digital images by acomputing device to generate three-dimensional image information for theselected body part or body area and generating clinical diagnosisinformation for the patient, wherein the clinical diagnosis comprisesone or more of: edema, lymphedema, venous eczema, ulceration, deep veinthrombosis, or post-thrombotic syndrome; and c) providing a compressiongarment from the three-dimensional image information and the clinicaldiagnosis information, wherein the compression garment includes at leastone compression value identified as therapeutically appropriate toprovide a prescribed or indicated amount of compression therapy to thepatient when the patient wears the compression garment on the selectedbody part or body area, and wherein the method is configured to monitora regression or progression of the clinical diagnoses in the patientover a period of time.
 16. A method of monitoring compression garmenttherapy for a patient comprising: a) acquiring digital images of aselected body part or body area of a patient receiving or in need ofcompression therapy, the selected body part or body area having asurface morphology and comprising: i. all or part of an arm; ii. all orpart of a leg; iii. a chest area; iv. a neck area; v. a hand; or vi. afoot; b) processing the digital images by a computing device to generatefirst three-dimensional image information for the selected body part orbody area; c) providing a first compression garment, wherein the firstcompression garment has dimensions and performance derived from thefirst three-dimensional image information and a first clinicalassessment, and wherein the first compression garment is configure to betherapeutically appropriate to provide compression therapy to thepatient when the patient wears the first compression garment; d)acquiring digital images of the selected body part or body area of thepatient after a first period of time and processing the digital imagesby the computing device to generate second three-dimensional imageinformation for the selected body part or body area; e) comparing thefirst three-dimensional image information with the secondthree-dimensional image information to generate a second clinicalassessment for the patient; and f) providing a second compressiongarment, wherein the second compression garment has dimensions andperformance derived from each of the first and second three-dimensionalimage information and the second clinical assessment, and wherein thesecond compression garment is configured to be therapeuticallyappropriate to provide compression therapy to the patient when thepatient wears the second compression garment.
 17. The method of claim16, wherein the second clinical assessment includes informationassociated with one or more of a change of volume, one or morecircumference changes, or swelling change measurement for the selectedbody part or body area when the second three-dimensional digital imagediffers from the first three-dimensional digital image.
 18. The methodof claim 16, wherein second clinical assessment includes one or moreindications of a need for lymphatic drainage for the selected body partor body areas.